Prevalence and Determinants of Wheezing and Bronchodilatation in Children With Cystic Fibrosis: A Retrospective Cohort Study.

Background: Many patients with cystic fibrosis (CF) wheeze, and are dubbed as having CF-asthma. Understanding the determinants of such wheezing may avoid unnecessary treatments and open newer treatment avenues. Objectives: Main: To evaluate the prevalence and characteristics of wheezing and a positive bronchodilatory response (BDR) in children with CF. Secondary: To identify the predictive markers and the impact of current wheezing a positive BDR. Methods: A retrospective single-center study in children with CF. We determined the characteristics of physician-reported wheeze in patients <6 years, and a BDR in patients aged 6-17 years. Anthropometric, lung function, laboratory, genetic and microbiological data were recorded in all groups. Variables were compared using the Chi2 and Student t-tests, and ANOVA. Results: 125 preschool and 69 school-aged children and adolescents with CF were included in the study. 71.2% of patients <6 years of age had had at least one episode of wheezing: 26.3% of patients were Transient Early Wheezers, 12.6% Late Onset Wheezers and 37.9% were Persistent Wheezers. The prevalence of a positive BDR was 73.5, 48.5, and 52.9% in the 6-8 years, 10-12 years, and 15-17 years age groups, respectively. Allergic factors were not predictive of wheezing in preschoolers. In the 6-8 years age group, the sum of wheal diameters of allergic skin prick tests (SPT, house dust mite + cat + dog dander) was greater in those with a BDR vs. no BDR (4 [2.0-8.8] vs. 1 [0-7.0] mm, p = 0.01). The presence of Pseudomonas aeruginosa in the bronchial secretions before 3 years of age was not significantly associated with either the presence of wheezing at the age of 6 years or a BDR in school-aged children and adolescents. The proportion of homozygous p.F508del patients was significantly lower in the group of patients who had wheezed by 6 years of age (60% vs. 72.7%, p = 0.009), but higher in the 6-8 years old group with a BDR vs. no BDR (64% vs. 36%, p = 0.04). Current wheezers at 6 years had a lower mean FEV1 vs. the non-current wheezers (91.5 ± 4.4% vs. 100.9 ± 2.4%; p = 0.047). Similarly, forced vital capacity (FVC) was significantly lower in the 6-8 years old group with BDR vs. no BDR (85 ± 19 vs. 101 ± 21%, p = 0.015). Conclusion: Wheezing and BDR are very frequent findings in children with CF. Current wheeze at the age of 6 years was associated with worse lung function. Labeling wheezing in CF as "CF-Asthma" is misleading since the determinants are different, and may lead to inappropriate prescriptions of inhaled steroids.

Sexual and reproductive health knowledge, behaviour and education needs of in-school adolescents in northern Nigeria.

Adolescence is marked by progression from the appearance of secondary sexual characteristics to sexual and reproductive maturity. Curiosity about bodily changes is heightened. However, adolescents' perceived sexuality education needs have been poorly documented. A survey of 989 adolescents from 24 North-Eastern Nigerian secondary schools yielded information on socio-demographic characteristics, reproductive health knowledge, sexual activities and sexuality education needs. Of the interviewed respondents, 72% of females had experienced menstruation. Overall, 9% were sexually active, 3.1% knew when ovulation occurs, 47% knew pregnancy could result from first coitus and 56% knew of contraception. 84% opined that adolescents should be given sexuality education but only 48.3% had received any. Sexuality education should be provided for in-school adolescents through their preferred and reliable sources of information.

Knowledge about Tuberculosis: A Precursor to Effective TB Control-Findings from a Follow-Up National KAP Study on Tuberculosis among Nigerians.

Tuberculosis (TB) constitutes a significant and major public health emergency globally. Nigeria is one of the 22 high burden Tuberculosis countries. A high level of community awareness and positive perception towards TB and its management is crucial for the success of any control strategy. A national baseline survey was conducted in 2008 and a follow-up study in 2012 to measure knowledge of TB among the general population. This study therefore evaluated the knowledge of the target population about Tuberculosis in the follow-up study. A cross-sectional study design was employed with a total of 3,021 respondents interviewed from six states selected randomly from each of the six geopolitical zones in the country. Quantitative and qualitative research methodologies were adopted. From the findings, about 60% of the respondents were aged between 21 and 40 years and more than half had secondary school education. Over 80% had ever heard about TB. Although there has been a significant improvement in correct knowledge of the cause of TB from baseline (19%) in 2008 to 26.5% in 2012 (p < 0.001), findings showed that prioritized interventions are needed to improve communication and information dissemination on Tuberculosis to the general public, to aid TB control and all prevention efforts.

Contraceptive implants.

In response to the need of some women for long-acting, effective and safe contraceptives, the scientific community developed non-biodegradable progestational subdermal implants that act by making the cervical mucus viscous, with ovulation inhibition and thinning of the endometrial lining. The contraceptive protection is within 24 hours and the cumulative failure rate is low. Contraceptive implants require little or no motivation following adequate counselling. In current use are multirod implants (Norplant I and Norplant II Jadelle) and single rod implant (Implanon and Uniplant). Although menstrual symptoms associated with progestational regimens are the major compliance and acceptability factors within the first year of use, menstrual disturbance generally improves. Continuation rates for implant use are high among those who have had adequate pre-insertion counselling because the perceived advantages greatly outweigh the nuisance effects. Other side effects of implants are similar to those observed with hormonal pills--headache, weight changes, mood swings and abdominal bloating. Training of physicians and nurses in the art of insertion and removal techniques is a pre-requisite for a successful implant programme. This should also be backed by integration of implants into the national commodity logistics systems to ensure adequate local budgetary provision for contraceptive implant procurement rather than reliance on donor supply.

Nomegestrol acetate contraceptive implant use by women with sickle cell disease.

OBJECTIVE: To assess the contraceptive effectiveness, safety, and potential health benefits of nomegestrol acetate contraceptive implant use by women with homozygous sickle cell disease (hemoglobin SS). METHODS: This was a prospective observation before and after insertion of nomegestrol acetate of 20 women with sickle cell disease (test group) compared with 10 women with similar sociodemographic backgrounds. Changes in hematologic and biochemical parameters and symptoms of sickle cell crisis were measured during 12 months of observation. RESULTS: After use of nomegestrol acetate for 1 to 9 months, the women in the test group had symptomatic improvement, with no crisis that required hospitalization and no deaths. Sickle cell symptoms persisted in the women in the control group, with 1 recorded death. Increases in F-cell and fetal hemoglobin parallel the observed clinical improvement in the treated women. There were no adverse hematologic or biochemical changes associated with the use of nomegestrol acetate implants. CONCLUSION: Nomegestrol acetate appears to be a safe and appropriate contraceptive for women with sickle cell disease, showing evidence of being a "stimulant" for F-cell reactivation, independent of F hemoglobin total production increase.

Comparative study on the efficacy, acceptability, and side effects of a contraceptive pill administered by the oral and the vaginal route: an international multicenter clinical trial.

The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.

PIP: The objective of this multicenter randomized clinical trail was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. This study started in June, 1987, and data collection extended up to April, 1992, at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. The 819 subjects were from 17 to 39 years of age, had already had at least one pregnancy, had had regular menstrual cycles for 3 months before, were exposed to the risk of pregnancy, and were not using any other method of contraception. 424 were randomly assigned to use the pills orally (which contained 250 mcg levonorgestrel and 50 mcg ethinyl estradiol), whereas 395 inserted the pills vaginally. 625 subjects completed at least 6 months of use, 326 used the pills orally and 299 used the pills vaginally. 385 subjects completed 1 year of pills use, 201 in the oral group and 184 in the vaginal group. The 1-year discontinuation rate per 100 subjects per year for the oral group was 34.71 +or- 2.42, while it was 36.35 +or- 2.53 for the vaginal group. This difference was not statistically significant. The only single reason of statistically significant difference for discontinuation was "desire for pregnancy" (p = 0.444). Paired value analysis of subjects completing 12 months of study showed that women in the oral group had a statistically significant increase in weight, from a mean of 55.8 kg at admission to a mean of 56.9 kg at 6 months (p 0.05) and 57.3 kg at 1 year (p = 0.05). The mean weight of the vaginal group increased from 56.52 kg to 57.22 kg (p = 0.036) at 12 months. Significantly more complaints of vaginal discharge were recorded in women using the pills by the vaginal route (p = 0.001). However, only one subject discontinued the pills because of vaginal discharge.

Nutrition in pregnancy: mineral and vitamin supplements.

Pregnancy is associated with physiologic changes that result in increased plasma volume and red blood cells and decreased concentrations of circulating nutrient-binding proteins and micronutrients. In many developing countries, these physiologic changes can be aggravated by undernutrition, leading to micronutrient deficiency states, such as anemia, that can have disastrous consequences for both mothers and newborn infants. Multiple micronutrients are often taken by pregnant women in developed countries, but their benefits are limited, except for prophylactic folic acid taken during the periconceptional period. Women in developing countries may benefit from multiple-micronutrient prophylaxis in pregnancy, but the underlying basis and rationale for changing from supplementation with iron and folate to supplementation with multiple micronutrients has not been debated in the context of existing program objectives. There is an urgent need for this discussion so that both program effectiveness and program efficacy can be improved.

Nutrition and obstructed labor.

Obstructed labor is one of the most common preventable causes of maternal and perinatal morbidity and mortality in developing countries. Among the common causes are cephalopelvic disproportion, malpresentation, and malposition. Recognizing the causes of obstructed labor is important if the complications are to be prevented. Adequate prevention, however, can be achieved only through a multidisciplinary approach aimed in the short term at identifying high-risk cases and in the long term at improving nutrition. Early motherhood should be discouraged, and efforts are needed to improve nutrition during infancy, childhood, early adulthood, and pregnancy. Improving the access to and promoting the use of reproductive and contraceptive services will help reduce the prevalence of this complication.

Leukocyte migration inhibition studies and neutrophil cell function during aging in Nigerians.

In this study, in vitro cell-mediated immune response was analysed in 150 healthy Nigerians between 6 and 95 years old by the leukocyte migration inhibitory factor (L-MIF) test. Lymphocytes were activated with the mitogen concanavalin A and candida, measles virus and mycobacterial antigens. Nonspecific cellular immune capacity was studied by the Nitroblue tetrazolium (NBT) test. Numerical estimates of leukocytes and lymphocyte subpopulations were done. Mean L-MIF activity obtained with the four lymphocyte activators decreased with rising age indicating a progressive decline in cellular immune function with age. There was no significant age-related change in formazan positivity rate for both unstimulated and stimulated NBT tests. No age-related change in number was observed for any of the leucocyte and lymphocyte subpopulations. These results show that cell-mediaging response in Nigerians immunity declines, but phagocyte function is unchanged during aging. Lymphocyte depletion or numerical alteration in resting T cell subsets could not be demonstrated to be responsible for depressed cell-mediated immunity in aging Nigerians.

Effects of a single contraceptive Silastic implant containing nomegestrol acetate on ovarian function and cervical mucus production during 2 years.

OBJECTIVE: To study the mechanism of action of Uniplant (South to South Corporation in Reproductive Health, Salvador, Brazil), a single Silastic capsule containing nomegestrol acetate (Lutenyl, Theramex, France) in women during 2 years. DESIGN: Comparison between the hormonal levels, follicular development, cervical mucus (CM) production, and endometrial thickness in the menstrual cycle before implant insertion and at 1, 6, 12, 18, and 24 months after implant insertion. PARTICIPANTS: A total of 15 women of reproductive age were enrolled for the 1st year of use. Twelve of these women continued for a 2nd year of Uniplant use. MAIN OUTCOME MEASURES: Hormonal plasma levels were measured in control cycles and at 1, 6, 12, 18, and 24 months of Uniplant use. Cervical mucus, follicular development, and endometrial thickness also were evaluated. RESULTS: In this study, Uniplant blocks ovulation in 86 percent of cycles studied. Disturbances in follicular growth were observed also. Cervical mucus was scanty and viscous in all women during this study. Endometrial thickness was <8 mm in all cycles studied. CONCLUSION: This study shows that Uniplant is a long-acting contraceptive that probably acts at the hypothalamic-pituitary levels, on the ovary, on CM production, and on the endometrium. These properties suggest the use of Uniplant as a contraceptive agent, especially if one considers the lack of androgenic and metabolic effects and the maintenance of periodic bleeding similar to menstruation.

PIP: A total of 15 healthy women volunteers were enrolled in this study. Their mean age was 23 +or- 1.2 years (range, 18-33 years), mean weight was 55.7 +or- 2.6 kg (range, 40-72 kg), and mean parity was 1.1 (range, 0-4). Venous blood samples were drawn every other day from day eight of the cycle until sonographic evidence of a 12-mm follicle, and then every day until sonographic evidence of follicular rupture and thereafter every other day until the next menstrual bleeding. The capsules were removed at the end of one year of Uniplant use, and a new capsule was inserted in 12 subjects. The blood samples for hormonal analyses were taken after 18 and 24 months of Uniplant use in the 12 women who continued in the study. Levels of luteinizing hormone (LH) were significantly lower than in the control cycles during the observation period (p .01, p .05). According to transvaginal sonography, four different patterns of follicular development were found: normal follicular growth and rupture, persistent follicle, follicular cysts, and no follicular growth. Follicular growth and rupture were observed in 20% of the treated cycles. Persistent follicles were present in approximately 15% of the treated cycles. Follicular cysts were observed in 29% of the cycles studied during 24 months of Uniplant use. All subjects had normal cervical cytology before starting treatment, after 12 months, and after 24 months of Uniplant use. The maximum cervical mucus score for pretreatment cycles was 12.8 +or- 0.4. Endometrial thickness was 8 mm in all cycles studied. 58% (7 of 12) of the women showed a normal menstrual cycle (26 to 32 days). 33% (4 of 12) of the women experienced one or two episodes of amenorrhea (90-134 days), whereas 8.3% of women (1 of 12) experienced episodes of spotting, six times in a period of 24 months of Uniplant use (10-30 days). Before Uniplant insertion, plasma concentration of sex hormone binding globulin was 72.3 nmol/L. After 24 months of Uniplant use, the concentration was 78.0 nmol/L.

Oral contraceptive marketing in Ibadan, Nigeria.

The demographic transition in Nigeria is gradually moving towards the second stage. There is clear evidence of a declining mortality but the fertility rate remains exceptionally high. A realistic approach towards reducing fertility rate is the use of oral contraceptive. This study assesses the distribution system of oral contraceptive in Ibadan, the second largest city in Nigeria. The findings revealed that the people are aware of modern oral contraceptives as they purchase them freely at chemist shops. But effective distribution is hampered by existing channels and high costs. A local source recommended is the proprietary medicine stores, often at convenient locations to the potential users of contraceptives. The current cost which is between $1.3 and $19.5 per couple-years of protection is exorbitant, consuming 0.5-7.8% of the gross annual income of the average individual. Therefore, the government should subsidize the prices of oral contraceptives, to facilitate freedom from the tyranny of excessive fertility.

Qualitative methods in operations research on contraceptive distribution systems: a case study from Nigeria.

This article discusses the application of qualitative methods in operations research on a family planning service delivery system. Market traders in Ibadan, Nigeria were trained to sell oral contraceptives, condoms, and spermicidal foaming tablets in a collaborative research project of the Fertility Research Unit of the University College Hospital, Ibadan, and the Center for Population and Family Health of Columbia University. Focus group discussion, participant observation, and semi-structured interviews were used to investigate the cultural acceptability of distribution of contraceptives in the market places and the motivations of participating traders. The strength of the market associations was a factor influencing acceptance of the project and the number of customers for the traders' other wares were found to positively influence the volume of sales of contraceptives. Traders were motivated by the status associated with participating in a program of a well-known health institution. Findings from qualitative research suggest areas for quantitative studies and vice versa in an interactive process.

Changes in carbohydrate metabolism during 30 months on Norplant.

During a 30-month period, changes in carbohydrate metabolism (measured by oral glucose tolerance test) were studied in 20 Norplant acceptors. Changes were first observed one month after Norplant insertion and peaked between 12-18 months. The area under the glucose curve rose by 12.3% and 40.5% one and 12 months post insertion, respectively. At 18, 24 and 30 months the rise was, respectively, 41.9%, 40% and 38.6%. Although the changes under the insulin curves were similar, the increase at one month was doubled (25.7%). Only fasting insulin values showed very slight and insignificant changes during the 30-month period. All the changes were, however, within the normal limits for healthy women. We conclude that although Norplant induces changes in carbohydrate metabolism, these changes remain within normal limits, peak at 12 months and either remain the same or decrease with time.

The effects of nomegestrol acetate subdermal implant (Uniplant) on carbohydrate metabolism, serum lipoproteins and on hepatic function in women.

This study was undertaken to assess possible variations in body weight, blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, SGPT, SGOT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (10%) of nomegestrol acetate during two years. A total of eighteen volunteers of reproductive age who desired to avoid conception were enrolled in this study. Subjects were healthy women with no contraindications to hormonal contraception. All women were investigated before starting treatment and were followed up for one year. At the end of one year the capsules were removed and a new capsule was inserted. Fasting blood samples were drawn at 8:00 to 8:30 am twice prior to implant insertion and then at the first, third, sixth and twelfth months and every six months thereafter. Body weight increased from 54.9 +/- 1.5 kg at admission to 55.3 +/- 2.0 kg at 12 months of use (p < 0.05) and to 56.0 +/- 2.7 kg at 24 months of use. A slight increase in both systolic and diastolic blood pressure was recorded at month 12 (p < 0.01). At month 24, blood pressure was not significantly different from admission values. All levels were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during twenty-four months of Uniplant use. A significant decrease in total cholesterol (p < 0.05) was observed in the third month while a significant decrease in HDL-C (p < 0.01) was observed only in the sixth month of Uniplant use.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: Possible variations in body weight, blood pressure, fasting glucose, HbA1C (glycosylated hemoglobin), insulin, total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides, serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), GGT, and bilirubin were assessed for 2 years. 18 healthy female volunteers with a mean age of 23.0 years and mean parity of 0.9 used a single subdermal Silastic implant (Uniplant) containing 55 mg (10%) of nomegestrol acetate. Fasting blood samples were drawn twice prior to implant insertion and then at the 1st, 3rd, 6th, and 12th months and every 6 months thereafter. Body weight increased from 54.9 kg at admission to 55.3 kg at 12 months of use (p 0.05) and to 56.0 kg at 24 months of use. Both systolic and diastolic blood pressure increased slightly at month 12 (p 0.01). Insulin, HbA1C, LDL-C, and GGT remained unchanged during 24 months of Uniplant use. A significant decrease in total cholesterol (p 0.05) was observed in the 3rd month, while a significant decrease in HDL-C (p 0.01) was observed only in the 6th month of Uniplant use. A significant increase in triglycerides (p 0.05) was observed only in the 12th month. Significant increases in fasting blood glucose levels (p 0.05 and p 0.01) were observed in the 3rd and 6th month, respectively, for 24 months of Uniplant use. Significant decreases in SGOT (p 0.05, p 0.01 and p 0.05) were observed in the 6th, 18th, and 24th months, respectively. A significant decrease in SGPT (p 0.05) was observed in the 18th month of Uniplant use. A significant increase in bilirubin (p 0.05) was observed only in the 3rd month of Uniplant use. Within the normal range, variation of fasting glucose was not correlated with changes in insulin levels and no clinical effects on lipoproteins, carbohydrate metabolism, insulin levels, and on hepatic function were observed in these women.

Carbohydrate metabolism before and after Norplant removal.

Changes in carbohydrate metabolism, measured by oral glucose tolerance test, were studied in Norplant users before and after removal. The mean area under the glucose curve rose from 24.7 min mmol/L before Norplant insertion to 35.1 min mmol/L before removal and decreased to 26.1 min mmol/L four weeks after Norplant removal. The areas before insertion and after removal were not statistically different (95% confidence interval -3.3 to 0.56, P = 0.16). The mean areas under the insulin curves before insertion (53.14 min uU/L) and after removal (59.46 min uU/L), however, were significantly different (95% confidence interval -7.64 to -5.0, P less than 0.0001). We conclude that changes in carbohydrate metabolism induced by Norplant are reversible once the implants are removed. While the changes in glucose induced by Norplant returned to pre-insertion levels within 4 weeks after removal, insulin changes were slower to return to pre-insertion values.

PIP: Physicians at the University College Hospital in Ibadan, Nigeria recruited 24 26-39 year old women who had use Norplant for 18-30 months between January 1986-July 1988 into a study to determine changes in carbohydrate metabolism before and after removal of Norplant. None of the women had diabetes mellitus. The women underwent a glucose tolerance test (GTT) before insertion, just before removal, and 30 days after removal. The mean area under the GTT curve increased from 24.7 min mmol/L before insertion to 35.1 min mmol/L before removal and decreased to 26.1 min mmol/L 30 days after removal (p.0001). Yet there was no statistical difference between the mean areas under the GTT curve before insertion and those after removal. Thus glucose levels returned to preinsertion levels shortly after removal. There were significant differences in the mean areas under the insulin curves between before insertion and after removal, however (5314 min uU/L vs. 59.46 min uU/L; p.0001). Thus insulin levels 30 days after removal did not return to preinsertion levels as rapidly as did glucose levels. These results suggest that carbohydrate metabolic changes may be significant in women with diabetes mellitus. Therefore physicians should monitor blood glucose levels in diabetics. The changes in carbohydrate metabolism caused by Norplant return to almost normal when it is removed.

Temporal relationship between Uniplant insertion and changes in cervical mucus.

This study was undertaken to determine the time required by a single implant containing nomegestrol acetate to affect cervical mucus production and sperm penetration in women. All subjects were investigated and, if necessary, treated for any kind of cervicitis or vaginitis prior to starting cervical mucus study. The subjects had not used hormonal contraception for at least three months prior to investigation. They were counseled to use condoms during this study and also to refrain from intercourse during the period of cervical mucus sampling. Follicular development and endometrial thickness were analyzed by transvaginal sonography. Cervical mucus examination, sperm penetration test, and transvaginal sonography were performed during the control cycle and during the first cycle of Uniplant use. Blood samples were taken for the measurement of estradiol, LH, and progesterone. Cervical mucus and sperm penetration tests were evaluated according to the World Health Organization (WHO) criteria. In the treated cycle, when cervical mucus reached a score of 8-10, Uniplant was inserted, independent of the day of the cycle. Cervical mucus was then collected at 0, 4, 8, 12, 24, 48, and 96 h later until a marked change in volume, consistency, ferning spinnbarkheit, and cellularity was observed. All samples were also used for sperm penetration test. Preovulatory estradiol and LH peak decreased significantly compared to pre-implant insertion. Progesterone levels were within the normal limit. Cervical mucus and sperm penetration tests were not affected by Uniplant in the first 12 h. Twenty-four hours after Uniplant insertion, cervical mucus and sperm penetration tests were affected in 70.6% of the women. Forty-eight hours after implant insertion, the women were affected. Follicular rupture occurred in the majority of the women 48 h after implant insertion. Based on these results, it is possible to conclude that Uniplant can affect estradiol and LH preovulatory peaks and disrupt the process of cervical mucus production and sperm penetration, but it was unable to prevent ovulation when inserted in the preovulatory phase.

PIP: In Brazil, physicians inserted one single capsule of the nomegestrol acetate contraceptive implant (Uniplant) subcutaneously in the gluteal region of 17 healthy female volunteers (mean age = 24.62 years) when their cervical mucus score was 8-10. They performed cervical mucus examination, sperm penetration test, and transvaginal sonography during the control cycle and during the first cycle of Uniplant use. They took blood samples to measure estradiol, luteinizing hormone (LH), and progesterone. Uniplant contained 55 mg of nomegestrol acetate. The researchers aimed to determine the time between Uniplant insertion and changes in cervical mucus and in the ability of sperm to exhibit forward motility in the cervical mucus. When Uniplant was inserted in the early follicular phase, the preovulatory peaks of estradiol and LH were significantly lower than preinsertion peaks (539.4 vs. 1087.1 pmol/l and 12 vs. 40.4 IU/l, respectively; p 0.01). The lower progesterone levels in the treatment cycle were not significantly different than preinsertion progesterone levels (46.6 vs. 53.8 nmol/l; p = 0.055). Ultrasonography and progesterone levels indicated that 16 of the 17 treatment cycles were ovulatory. Neither cervical mucus nor sperm penetration was affected in the first 12 hours postinsertion. By 24 hours postinsertion, 70.6% of the women exhibited significant changes in both cervical mucus and sperm penetration. At the end of 48 hours, all 17 women had these changes. These findings suggest that Uniplant inserted in the periovulatory phase affects cervical mucus production, sperm penetration, and preovulatory peaks of LH and estradiol but does not affect ovulation.

The effects of nomegestrol acetate subdermal implant (Uniplant) on serum cholesterol, triglycerides, and lipoproteins in Nigerian users.

The study was conducted to assess the effects of a nomegestrol acetate subdermal contraceptive implant (Uniplant(R)) on the lipid profiles of indigenous Nigerian women. Cholesterol content of the major lipoproteins, along with total cholesterol and triglycerides, were measured in fasting blood samples collected before implant insertion and then at months 1, 3, 6, and 12 of use. All volunteers were of the reproductive age, healthy, and had no contraindications to hormonal contraception. The mean levels of cholesterol and low density lipoprotein-cholesterol (LDL-C) increased gradually, albeit insignificantly, from insertion to month 12 of implant use. An initial decline in the mean levels of high density lipoprotein-cholesterol (HDL-C), reaching a minimal level (37.31 +/- 4.95 mg/dl) at month 3 of implant use, was observed. This was followed by a gradual rise that peaked (39.73 +/- 5.53 mg/dL) at month 12. These values were, however, not significantly different from the preinsertion value. The only significant difference (p <0. 005 ) was in the mean level of triglycerides at month 12 (90.90 +/- 17.75 mg/dL) when compared with the preinsertion mean level of 81.77 +/- 24.14 mg/dL. Both values were, however, within normal limits. These results indicate that Uniplant does not have a deleterious effect on the lipid profiles of Nigerian acceptors and can be safely prescribed to women seeking contraception.

Androgen levels in women using a single implant of nomegestrol acetate.

This study was undertaken to evaluate the effects of a single implant containing nomegestrol acetate (Uniplant) on plasma levels of sex hormone-binding globulin (SHBG), testosterone, free testosterone, androstenedione and on blood pressure, body weight, and the development of acne vulgaris. Plasma levels of sex hormone-binding globulin, testosterone, free testosterone and androstenedione were measured. Blood pressure and body weight were determined. The development of acne vulgaris was evaluated. Total testosterone and androstenedione decreased significantly during two years of Uniplant use but all levels were within the normal range. There were no significant differences in sex hormone-binding globulin and free testosterone during 24 months of Uniplant use. All changes observed in this study were within normal range. SHBG was not affected by Uniplant use. No significant increase in androgen levels and in the development of acne vulgaris was observed in these women using nomegestrol acetate implant during two years. Based on these results, it is possible to conclude that Uniplant had no androgenic effect in women during this study.

PIP: In Bahia, Brazil, clinical researchers enrolled 18 women of reproductive age into a clinical study examining the effects of a single contraceptive implant (Uniplant) on plasma levels of sex hormone-binding globulin (SHBG), testosterone, free testosterone, androstenedione, and on blood pressure, body weight, and the development of common acne. They followed the women for 24 months. The implant consisted of silastic tubing filled with 55 mg crystalline, finely ground nomegestrol acetate. The implant did not significantly change the plasma level of SHBG (69.2 nmol/l at baseline and 59.8 nmol/l at 24 months). The plasma level of total testosterone fell from 1.9 to 1.2 nmol/l at 12 months (p 0.01) and to 0.8 nmol/l at 24 months (p 0.01) (p = 0.019 for entire study period). Yet all these levels fell within the normal range. The free testosterone plasma level did not change significantly (2.6 pmol/l at baseline and at 24 months). The plasma level of androstenedione fell steadily throughout the study period (8.7 nmol/l at baseline, 6.2 at 6 months, 4.8 at 12 months, 3.3 at 18 months, and 3.2 at 24 months; p = 0.029), probably a result of ovulation inhibition. Body weight increased from 54.7 kg at baseline to 55.3 kg at 12 months (p 0.01) and to 56 kg at 24 months. Between baseline and 12 months of Uniplant use, both systolic and diastolic blood pressure increased (p 0.01) but did not change significantly thereafter. No woman developed acne. These findings indicate that Uniplant does not induce an androgenic effect in women during two years of use.

A new vaginal antimicrobial contraceptive formulation: phase I clinical pilot studies.

Pilot clinical trials were performed with a new vaginal suppository called "Long Acting, Sustained Release of Spermicide" ("LASRS"). No visual or colposcopic lesions or patient complaints occurred as a result of using LASRS with increasing doses of nonoxynol-9 (up to 20%) for 5 days or of applying the highest dose of nonoxynol-9 (20%; total 400 mg) for 8 h. Colposcopic or visual lesions were also not induced when LASRS with 20% nonoxynol-9 was used for 7 consecutive days by the study participants except for those who developed symptomatic monilia vaginitis. Symptoms were reported although these were mostly minor. A long-lasting, bioadhesive, translucent layer (film) of formulation formed over the vaginal and cervical surfaces. Postcoital spermicidal studies showed LASRS to be highly effective for prolonged periods of time. Although intercourse was delayed for 5 to 8.5 h after insertion of the formulation, an average of only 0. 2 motile sperm/HPF could be found in cervical mucus. These studies suggest LASRS to possess advantages over presently marketed formulations by having long-term efficacy and by forming a bioadhesive, presumably protective layer over the genital tract epithelium. The results also suggest the formulation to decrease the vaginal irritation caused by nonoxynol-9 as noted by colposcopy. These pilot data support a more extensive study with the LASRS suppository.

Carbohydrate metabolism in sickle cell patients using a subdermal implant containing nomegestrol acetate (Uniplant).

Uniplant, a second-generation contraceptive implant, has been demonstrated to promote a significant improvement in the overall well-being of women with sickle cell anemia. It has been suggested that the discrete increase in blood glucose levels observed in Uniplant users could be a contributory factor for clinical improvement. Ten healthy sickle cell patients were enrolled in the study. An oral glucose tolerance test was performed prior to implant insertion and at 1, 6, and 12 months of therapy. Blood glucose and insulin were measured before and at 30, 60, 120, and 180 min after a 75-g glucose load. The glucose and insulin areas under the curves were calculated. Fasting glycosylated hemoglobin was also measured. No significant changes were observed in glycosylated hemoglobin, glucose or insulin. We conclude that Uniplant is a safe contraceptive for sickle cell patients.