Oral contraception: current use and attitudes.

Oral contraception (OC) has been available for almost four decades. During this time, changes in contraceptive use in general and OC in particular have occurred. Knowledge and attitudes about OC may not always reflect trends in use. Contraceptive use data from 1965-1995 show that OC continue to be the method chosen consistently by more than one-quarter of women contraceptors. Probably even more women would use the pill if they had more accurate information regarding the higher failure rates with barrier methods (especially the condom), if misperceptions about OC safety were put to rest, and if greater awareness of the noncontraceptive health benefits of OC could be achieved. Increased education and awareness of women as well as their healthcare providers has the potential to positively affect future contraceptive use.

PIP: During the four decades that oral contraceptives (OCs) have been available to US women, important changes have occurred in their use patterns. The mass media, health care providers, and health insurance companies all have shaped these patterns. The media continue to emphasize the health risks of OC use, despite the fact that changes in the steroid content of OCs and identification of patient risk factors have eliminated or minimized many adverse outcomes. Educational efforts by health care providers on the noncontraceptive benefits of OC use have been inadequate to counteract media-promoted public misperceptions. Inaccurate information may lead women to select a method that lacks the appropriate degree of effectiveness and a consequent increased risk of unintended pregnancy. Two measures of socioeconomic status--income and education--exert a major influence on the choice of a contraceptive method by US women. Low-income women with a high school education or less are more likely to use female sterilization and less likely to use OCs than women with more education and income. Future contraceptive trends in the US will depend on factors such as the changing age distribution of women, revised upper age limits for OC use, the effects of delayed childbearing and sterilization, the impact of new methods, the availability of abortion, and concerns about HIV infection and other sexually transmitted diseases.

A multicentred phase III comparative clinical trial of Mesigyna, Cyclofem and Injectable No. 1 given monthly by intramuscular injection to Chinese women. I. Contraceptive efficacy and sid effects.

A phase III clinical study was carried out among 5680 fertile Chinese women to evaluate efficacy and side effects of three monthly injectable contraceptives: Mesigyna, Cyclofem and Chinese Injectable No. 1. When used in a once-a-month treatment schedule (part 1 of study), the effectiveness of Chinese Injectable No. 1 was unacceptably low; 36 pregnancies occurred during the first 1743 women-months of use, 16 before the second injection. The study was restarted with a revised injection schedule for Injectable No. 1: two injections separated by 9 +/- 1 days during the first month and subsequent injections given 10-12 days after the onset of bleeding, or if no bleeding occurred, 28 days after previous injection. In part 2 of the study, 988, 990 and 992 subjects were provided Mesigyna, Cyclofem and Injectable No. 1, respectively. Life-table pregnancy rates at one year were 0.41%, 0% and 0.77% (p < 0.05), respectively; the overall discontinuation rates at one year were 13.9%, 19.1% and 20.4% (p < 0.001). Discontinuation rates for bleeding problems were significantly different between the groups: discontinuation rates for amenorrhea were 0.58%, 3.71% and 0.68% (p < 0.001) for Mesigyna, Cyclofem and Injectable No. 1; for other bleeding problems, the rates were 4.88%, 8.38% and 12.64% (p < 0.001). There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight changes after one year of use were small: 0.73, 0.86 and 0.17 kg for the three groups, respectively. Both Mesigyna and Cyclofem were very effective for contraception, but Mesigyna appeared to be tolerated slightly better with regard to cycle control; the modified dose regimen for Injectable No. 1 also gave a low pregnancy rate but was associated with higher rates of discontinuation.

A multicentred phase III comparative clinical trial of Mesigyna, Cyclofem and Injectable No. 1 given by intramuscular injection to Chinese women. II. The comparison of bleeding patterns.

Between 1988 and 1992, a randomized phase III clinical trial was conducted in China to compare three monthly injectable contraceptives: Mesigyna, Cyclofem and Injectable No. 1. This paper presents a detailed analysis of the menstrual diaries provided by 5098 (89%) of the subjects. In total, 902, 903 and 913 diaries were analyzed to compare bleeding patterns induced by Mesigyna, Cyclofem and Injectable No. 1. The first withdrawal bleeding usually occurs 14-20 days after the first injection for all three of these preparations. Thereafter, 50% of Mesigyna users had precisely 3 bleeding/spotting episodes every 90 days, 50% of Cyclofem users had 2-3 and 50% of Injectable No. 1 users had 3-4 episodes every 90 days. Relative to users of Mesigyna or Cyclofem, Injectable No. 1 users had 2-3 more bleeding/spotting days, and a shorter length of bleeding/spotting-free intervals in each period. 63.7%, 41.4% and 60.6% of subjects using Mesigyna, Cyclofem and Injectable No. 1, respectively, had bleeding patterns similar to their untreated patterns in the first 90-day period. The percentages increased to 82.2% 67.8% and 75.0% in the fourth 90-day period. A total of 1815 diaries for Mesigyna and 1802 for Cyclofem were analyzed for more in depth comparison of these two methods. The number of bleeding/spotting days over four periods showed little difference between the two group, but there were more spotting days and there was greater individual variability among Cyclofem users.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: Between October 1988 and July 1990, a randomized multicentered phase III clinical trial was conducted in three provinces of China to compare three monthly injectable contraceptives (Mesigyna [50 mg norethisterone enanthate + 5 mg estradiol valerate], Cyclofem [25 mg medroxyprogesterone acetate + 5 mg estradiol cypionate], and Injectable No.1 [250 mg 17-hydroxyprogesterone caproate + 5 mg estradiol valerate]). A detailed analysis of the menstrual diaries of 5098 women aged 18-35 years compared the vaginal bleeding patterns associated with the injectables. Women in all three groups experienced more bleeding/spotting (B/S) days, more bleeding episodes, shorter bleeding-free intervals, and larger variability during the first 90 days than during the following three 90-day periods (p 0.001). 90% of Cyclofem users had 1-4 B/S episodes. 90% of Mesigyna users had 2-4.2 B/S episodes. Cyclofem users had more spotting days than did Mesigyna users in each 90-day period (5-8 vs. 5-6). Acceptable bleeding patterns (i.e., bleeding patterns similar to untreated patterns) predominated, on the most part, in all four periods (63.7-82.2% for Mesigyna users, 41.4-67.8% for Cyclofem users, and 60.6-75% for Injectable No.1 users). Acceptability increased with each 90-day period for all three injectables. Acceptability of bleeding patterns was much higher among Mesigyna users than Cyclofem users (p 0.001). Prolonged bleeding, followed by irregular bleeding and frequent bleeding, were the most common bleeding disturbances. Irregular bleeding decreased with time. 79.1% of Mesigyna and Cyclofem users who finished the study had an acceptable pattern. 70.7% of women who stopped for non-bleeding reasons had an acceptable pattern compared to 31.3% of those who stopped for bleeding reasons. These findings show that Mesigyna users experienced better cycle control and more acceptable bleeding patterns than did the users of the other two injectables.

Development and validation of a direct, non-destructive quantitative method for medroxyprogesterone acetate in a pharmaceutical suspension using FT-Raman spectroscopy.

A simple linear regression method was developed and statistically validated for the direct and non-destructive quantitative analysis--without sample preparation--of the active pharmaceutical ingredient (API) medroxyprogesterone acetate (MPA) in an aqueous pharmaceutical suspension (150 mg in 1.0 ml) using FT-Raman spectroscopy. The linear regression was modelled by plotting the highest peak intensity of the vector normalized spectral band between 1630 and 1590 cm-1 against different MPA standard suspension concentrations. At this band, no spectral interferences from additives in the suspension are observed. The validated model was used for the quantification of a commercial suspension (150 mg in 1.0 ml) of the commercialized preparations. The same standards and samples were used, respectively, for the development and validation of a simple linear regression model and for the quantitative determination by means of HPLC-with sample preparation-as described for the related substances of MPA in the Ph. Eur. IV. The quantification results obtained by the FT-Raman method corresponded with the claimed label concentration (150.01+/-0.96 mg/ml (n=6)). Applying the HPLC method, however, a systematic error was observed (157.77+/-0.94 mg/ml (n=6)). The direct FT-Raman method hence appears the most reliable for the quantification of the MPA component in suspension, compared to the HPLC method that requires sample preparation. The latter method provides a systematic error because the exact volume or density of a suspension sample is unknown. A precise isolation of fixed volumes from a suspension is rather unfeasible because of the continuous sagging of the suspended particles and their sticking to the used materials in the isolation process.

Injectable contraceptive sales at licensed chemical seller shops in ghana: access and reported use in rural and periurban communities.

CONTEXT: Most women in Ghana obtain oral contraceptives and condoms from shops run by licensed chemical sellers, but such shops are not legally permitted to sell the country's most widely used method, the injectable. Allowing shops to sell the injectable could increase access to and use of the method. METHODS: In 2012-2013, semistructured telephone interviews were conducted among convenience samples of 94 licensed chemical seller shop operators in two districts who were trained to sell the injectable and of 298 women who purchased the method from these shops. Follow-up interviews were conducted with 92 clients approximately three months after their initial injectable purchase. RESULTS: Ninety-seven percent of shop operators reported selling the injectable, and 94% felt sufficiently trained to provide family planning methods and services. Virtually all sellers (99%) referred clients to a hospital or health facility for injection; none provided injections themselves. Fifty-six percent of injectable clients were new family planning users. Of those who completed a follow-up interview, 79% had purchased the injectable again from a shop. Virtually all clients (97%) reported getting their injection at the health facility to which they were referred by the seller. Women cited trust, convenience and commodities being in stock as key reasons for purchasing from a shop. CONCLUSION: Licensed chemical seller shop operators can safely sell the injectable and refer clients to health facilities for screening, counseling and injection.

Reduced community access to a key contraceptive: public health consequence from false suspicion of HIV-contaminated injectables.

BACKGROUND: This study was conducted to investigate a report of positive test results with DMPA on an HIV rapid test. Suspecting HIV contamination, the Zambian Ministry of Health initiated a product withdrawal pending full evaluation. STUDY DESIGN: DMPA was evaluated for compliance to product specifications. Contamination with HIV and blood components was investigated with PCR and human IgG ELISA. The performance of Genie II, Unigold and Determine HIV rapid tests was evaluated using DMPA. RESULTS: DMPA was found compliant with product specifications and negative for HIV and human IgG. DMPA impaired the performance of HIV rapid tests resulting in false-positive/indeterminant results. Rapid test results using polysorbate 80 (formulation component of DMPA) mimicked results obtained with DMPA. CONCLUSIONS: The DMPA sample was negative for HIV and human IgG. Formulation components may have led to the interpretation of false-positive results, reinforcing the need to validate the sample type used in any test. DMPA use was reinstated in Zambia, minimizing the public health impact that resulted from the initial rapid test results.

Introductory trial of the once-a-month injectable contraceptive, Cyclofem, in Indonesia.

Cyclofem, a once-a-month injectable hormone contraceptive, contains medroxyprogesterone acetate, 25 mg and estradiol cypionate, 5 mg. Indonesia is one of the countries participating in an introductory trial in collaboration with the World Health Organization (WHO) under the Human Reproduction Program (HRP). The main purpose of the trial is to assess, through a limited cohort of users, both problems and user needs in the program situation with regard to safety, efficacy, acceptability, and causes of discontinuation in the Indonesian context. Data based on the trial (March 1990-February 1992) indicate that the Cyclofem women complained of dizziness, nausea, bleeding problems, migraine, vomiting, amenorrhea, allergies and hypertension during the use of Cyclofem. However, it was found that the complaint rates decreased with increased duration of use. The life table continuation rates indicate that about 80% and 66% continued use at the end of 6 months and 12 months, respectively. Personal reasons account for the highest proportion of discontinuation, followed by desire for pregnancy and lost-to-follow-up.