Efficacy and Safety of Appetite-Stimulating Medications in the Inpatient Setting.

BACKGROUND: Hospitalized patients are subject to acute illness and stress which may impact appetite or weight. Loss of appetite may lead to increased morbidity or mortality. Medications such as dronabinol, megestrol, and mirtazapine are used for weight gain in the outpatient setting; however, there is limited information about safety or effectiveness when initiated inpatient. OBJECTIVES: To analyze the effectiveness and safety of appetite-stimulating medications in hospitalized patients. METHODS: This was a retrospective cohort study of hospitalized patients initiated on dronabinol, megestrol, or mirtazapine for appetite. The primary outcome was change in meal intake between drug initiation and discontinuation. Secondary outcomes included documented improvement in appetite, change in weight and various laboratory parameters, and incidence of adverse effects. RESULTS: A total of 38 patients met inclusion criteria, and mirtazapine was most commonly used (42%). There was no significant difference between groups of appetite-stimulating medications with regard to mean change in meal intake, weight, albumin, or documented improvement in diet. Within groups, each agent showed numerical improvement in percentage meal intake, with a mean change from initiation to discontinuation of 17.12%. Almost half (48%) of the patients experienced improvement in diet after the start of medications. No serious adverse effects were observed. Conclusion and Relevance: In inpatients, there was no difference in change in meal intake or weight between dronabinol, megestrol, or mirtazapine, but they may show numerical improvements in meal intake. To our knowledge, this is the first study to evaluate the use of dronabinol, megestrol, and mirtazapine initiated in the inpatient setting.

Ultra-performance liquid chromatography-tandem mass spectrometry assay for determination of plasma nomegestrol acetate and estradiol in healthy postmenopausal women.

A highly sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry method is described for the simultaneous determination of nomegestrol acetate (NOMAC), a highly selective progestogen, and estradiol (E2), a natural estrogen in human plasma. NOMAC was obtained from plasma by solid-phase extraction, while E2 was first separated by liquid-liquid extraction with methyl tert-butyl ether followed by derivatization with dansyl chloride. Deuterated internal standards, NOMAC-d5 and E2-d4 were used for better control of extraction conditions and ionization efficiency. The assay recovery of the analytes was within 90-99%. The analytes were separated on UPLC BEH C18 (50 × 2.1 mm, 1.7 µm) column using a mobile phase comprising of acetonitrile and 3.0 mm ammonium trifluoroacetate in water (80:20, v/v) with a resolution factor (Rs ) of 3.21. The calibration curves were linear from 0.01 to 10.0 ng/mL for NOMAC and from 1.00 to 1000 pg/mL for E2, respectively. The intra- and inter-batch precision was ≤5.8% and the accuracy of quality control samples ranged from 96.7 to 103.4% for both analytes. The practical applicability of the method is demonstrated by analyzing samples from 18 healthy postmenopausal women after oral administration of 2.5 mg nomegestrol acetate and 1.5 mg estradiol film-coated tablets under fasting.

Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and oestradiol: a multicentre, prospective cohort study (BOLERO).

OBJECTIVE: The aim of the study was to examine treatment continuation and satisfaction over 1 year among women receiving nomegestrol acetate (NOMAC)/oestradiol (E2) combined oral contraception (COC) in real-world clinical practice. METHODS: The 17ß-Estradiol and Nomegestrol Acetate (BOLERO) Study is an observational, non-interventional, prospective, multicentre cohort study of premenopausal women (aged 18-50 years) who received prescription NOMAC/E2 (2.5 mg/1.5 mg) for contraception during routine clinical practice. Assessments were carried out at enrolment and at 3, 6 and 12 months. Probability of treatment continuation through 12 months (primary outcome) was examined using Kaplan-Meier survival analysis. Secondary outcomes included treatment satisfaction, menstrual cycle-related symptoms, libido and adverse events (AEs). RESULTS: Of 298 enrolled women, 292 were evaluable. The probability of NOMAC/E2 continuation through 12 months was 73.7% (95% confidence interval [CI] 68.0%, 78.5%). Satisfaction with NOMAC/E2 increased from 56.9% (37/65) of women at initial evaluation to 89.2% (58/65) of women at 12 months. Physician ratings at 12 months showed satisfactory to very satisfactory in 84.0% (168/200) of women. Libido was not affected. Menstrual cycle-related symptoms significantly declined from enrolment (6.04 ± 4.32) to 3 months (3.25 ± 3.05) and 12 months (2.62 ± 2.74; p < .0001). Treatment-related AEs were reported by 38.7% (113/292) of women. CONCLUSION: The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms.

A comparison between the effects of metformin and megestrol on simple endometrial hyperplasia.

INTRODUCTION: Endometrial hyperplasia is one of the most serious causes of severe abnormal bleeding and also can be a precursor of endometrial carcinoma. OBJECTIVE: The purpose of the present study was to compare the effects of metformin and megestrol on the endometrial hyperplasia. METHODS: The study was performed as a randomized clinical trial on 42 cases of histopathologically confirmed simple endometrial hyperplasia without atypia. The eligible women were randomly assigned into two groups. In metformin group, metformin was prescribed, 500 mg twice a day (1000 mg daily), for a duration of 4 weeks, and then, followed by 1500 mg daily, for 8 more weeks. In the megestrol group, megestrol was prescribed 40 mg daily for 12 weeks. At the end of the duration of the treatment, endometrial sampling was performed and the results were compared between the two groups. RESULTS: The women of the two groups did not have significant difference according to age, BMI and gravidity, parity and history of abortion. Overall, 18 women (81.8%) in metformin group and 12 women (60%) in the megestrol group had normal endometrial histology, after 12 weeks of treatment (p = 0.11). CONCLUSION: Metformin is comparable with megestrol for the treatment of simple endometrial hyperplasia.

The sexuological impact of hormonal contraceptives based on their route of administration.

Evidence on the effects of hormonal contraceptives on female sexuality is conflicting. We enrolled 556 women, divided into six groups: two composed of subjects using a combined hormonal contraceptive (COC) containing 0.020 ("COC20") and 0.030 ("COC30") mg of ethynyl estradiol (EE), "natural", using COC containing 1.5 mg of estradiol (E2), "ring", using a vaginal ring releasing each day 0.015 mg of EE + 0.120 of etonogestrel, "subcutaneous", using a progestin only subcutaneous contraceptive implant releasing etonogestrel and "controls", using no hormonal contraceptive methods. The subjects were required to answer to the McCoy female sexuality questionnaire and were subjected to a blood test for hormonal evaluation. An ultrasound evaluation of the dorsal clitoral artery was also performed. The higher McCoy sexological value were recorded in the subdermal group; significant differences were recorded among the groups in terms of hormone distribution, with the higher levels of androstenedione in subdermal and control groups. The ultrasound evaluation of dorsal clitoral artery shows a significative correlation between pulsatility and resistance indices and orgasm parameters of McCoy questionnaire. The recorded difference in the sexual and hormonal parameters among the studied hormonal contraceptives may guide toward the personalization of contraceptive choice.

The use of oral nomegestrol acetate/estradiol in rapid and random start preparation of endometrium before office hysteroscopic polypectomies: A multicenter, prospective, randomized controlled trial.

OBJECTIVE: To evaluate the use of oral nomegestrol acetate/estradiol in random start rapid preparation of endometrium before office hysteroscopic polypectomy. STUDY DESIGN: Multicenter, prospective, randomized controlled trial. SETTING: University hospitals. PARTICIPANTS: 80 adult women undergoing office hysteroscopic polypectomy between January 2023 and March 2024 were randomized to intervention (n = 40) or control (n = 40). Exclusion criteria included the presence of endouterine pathology other than endometrial polyps solely. METHODS: Subjects in the intervention group were treated with oral nomegestrol acetate/estradiol 1.5 mg/2.5 mg/day started taking the drug from an indefinite time in the menstrual cycle (random start) for 14 days. Subjects in the control group did not receive any pharmaceutical treatment and underwent polypectomy between days 8 and 11 of the menstrual cycle. RESULTS: On the day of the procedure, the difference in pre- and post-office hysteroscopic polypectomy endometrial ultrasound thickness was statistically significant between the two groups, with endometrial thickness in both measurements being thinner for the intervention group (p < 0.001). In the nomegestrol acetate/estradiol-treated group, compared with the control, there was also a statistically significant difference in the physician's assessment of the quality of endometrial preparation (p < 0.001), the quality of visualization of the uterine cavity (p < 0.001), and satisfaction with the performance of the procedure (p < 0.001). Finally, all surgical outcomes analyzed were better in the treatment group. CONCLUSION: Treatment with nomegestrol acetate/estradiol could provide rapid, satisfactory and low-cost preparation of the endometrium before office polypectomy, thus improving surgical performance and woman's compliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT06316219.

Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17ß-estradiol in comparison to levonorgestrel/ethinylestradiol.

OBJECTIVE: To compare the effects of a monophasic combined oral contraceptive containing nomegestrol acetate/17ß-estradiol (NOMAC/E2) on bone mineral density with a combined oral contraceptive containing levonorgestrel/ethinylestradiol (LNG/EE). DESIGN: Prospective, randomized, open-label, comparative clinical study. SETTING: Gynecology center in Norway. POPULATION: One hundred and ten women (20-35 years old) actively seeking contraception. Methods. For 26 consecutive 28-day cycles, women received one of the following two treatments: NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n= 56); or LNG/EE (150 µg/30 µg) in a 21/7-day regimen (n= 54). Main outcome measures. Bone mineral density of the lumbar spine, femoral neck, hip and trochanter (measured by dual energy X-ray absorptiometry); associated z-scores of the lumbar spine and femoral neck. RESULTS: In NOMAC/E2 users, mean (±SD) z-score change from baseline for lumbar spine and femoral neck were 0.019 ± 0.242 and -0.007 ± 0.228, respectively, vs. 0.121 ± 0.269 and 0.044 ± 0.253 in LNG/EE users, respectively. Differences between treatment groups were not significant (p= 0.19 and p= 0.57, respectively). There were no significant differences between changes in hip and trochanter z-scores between NOMAC/E2 and LNG/EE treatments. CONCLUSIONS: After two years, NOMAC/E2 had no clinically relevant effect on bone mineral density. No significant difference in the effect on bone mineral density between NOMAC/E2 and LNG/EE was observed.

Hormone replacement therapy regimens in chemotherapy-induced premature ovarian failure and the subsequent correction of hormone levels.

OBJECTIVES: Premature ovarian failure (POF) is a consequence of gonadotoxic chemoradiotherapy given in antyneoplasia treatment. In young women it will correlate with menopausal symptoms which tend to appear due to depleted ovarian follicle reserve. DESIGN: It was a case series study that included women 18-50 years old who were treated for malignancy with gonadotoxic chemioradiotherapy. We have measured blood hormonal levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and progesterone within one month of various hormone replacement therapy (HRT). RESULTS: We have observed different kind of hormonal reaction according to FSH, LH, estradiol and progesterone levels due to various hormonal replacement therapy. The administration of various HRT regimens presented with a decrease in the blood concentration of estradiol E2 and progesterone and a concomitant increase of FSH and LH. These findings demonstrate a shift to physiological ranges and a simultaneous improvement of symptoms associated with CI-POF. CONCLUSIONS: The most appropriate therapy needs to be selected according to the patient's alleviation of symptoms and correction of blood hormone levels.

[Zoely, a combined oral contraceptive, monophasic pill containing estradiol and nomegestrol acetate]. / La médicament du mois. Zoely, une association monophasique d'estradiol et d'acétate de nomégestrol.

A new combined oral contraceptive called Zoely has just been marketed in Belgium. It contains nomegestrol acetate, a progestin known for its high contraceptive reliability based on its antigonadotropic power and long half-life. This progestin is associated with estradiol and Zoely is devoid of ethinyl estradiol, which is the usual component of the majority of combined oral contraceptives and is primarily responsible for thrombotic side effects of the pill. The compositon and type of regimen of this new oral contraceptive contribute to its efficacy and excellent clinical tolerance.

Estradiol + nomegestrol. Oral contraceptive claimed to be more natural, but presenting no obvious advantages.

No evidence of an advantage over standard oestrogen-progestin combinations, but as many serious adverse effects as with ethinylestradiol + drospirenone.

[Oral combined hormonal contraception containing nomegestrol acetate and 17beta-oestradiol--the statement of Polish Gynecological Society Experts Group]. / Stanowisko Ekspertów Polskiego Towarzystwa Ginekologicznego. Doustna zlozona antykoncepcja hormonalna oparta na octanie nomegestrolu i 17beta-estradiolu.

Nomegestrol acetate (NOMAC) combined with E2 (Zoely) is a monophasic oral contraceptive (OC) which safety and efficacy was confirmed in a number of level I evidence clinical trials. Zoely is highly effective OC, especially in overweight and obese patients, with good cycle control, safe and well tolerated. NOMAC/E2 combination causes no or minimal weight gain and is characterized by minimal influence on bone mineral density or blood pressure and presence of acne. Moreover lipids profile, carbohydrates metabolism, haemostasis and endocrine glands functioning were not affected. High tolerance and acceptance of NOMAC/E2 combination by women, low adverse event profile, fast recovery of ovarian activity and ovulation is a reasonable treatment tool in everyday practice.

Comparison of a 24-day and a 21-day pill regimen for the novel combined oral contraceptive, nomegestrol acetate and 17ß-estradiol (NOMAC/E2): a double-blind, randomized study.

BACKGROUND Nomegestrol acetate/17ß-estradiol (NOMAC/E(2)) is a new monophasic oral contraceptive combining NOMAC (2.5 mg), a highly selective progesterone-derived progestogen, with E(2) (1.5 mg), which is structurally identical to endogenous estrogen. The objective of this study was to compare the effects on ovarian activity of two different NOMAC/E(2) regimens. METHODS This was a double-blind, randomized study. Healthy, premenopausal women (aged 18-38 years, previous menstrual cycle length 28 ± 7 days) were randomized by computer-generated code to once-daily NOMAC/E(2) for three consecutive 28-day cycles: either 24 days with a 4-day placebo interval (n = 40) or 21 days with a 7-day placebo interval (n = 37) per cycle. Follicular growth (primary outcome measure), plasma hormone profiles and bleeding patterns were assessed. RESULTS There was no evidence of ovulation during treatment with either NOMAC/E(2) regimen. The largest follicle diameter was significantly smaller in the 24-day group than in the 21-day group [mean (SD) mm in cycle 2: 9.0 (3.0) versus 11.3 (5.3) (P = 0.02); in cycle 3: 9.2 (3.0) versus 11.5 (6.0) (P = 0.04)]. Mean FSH plasma levels were significantly lower in the 24-day versus the 21-day group on Day 24 of cycles 1 and 2. Withdrawal bleeding duration was significantly shorter in the 24-day than in the 21-day group [mean (SD) days after cycle 1: 3.5 (1.3) versus 5.0 (2.6) (P = 0.002); after cycle 2: 3.9 (1.6) versus 4.8 (1.7) (P = 0.03)]. CONCLUSIONS The 24-day NOMAC/E(2) regimen was associated with greater inhibition of follicular growth and shorter duration of withdrawal bleeding than the 21-day regimen, suggesting the shorter pill-free interval results in a greater margin of contraceptive efficacy and tolerability, and fewer withdrawal symptoms.

Antiemetic activity of megestrol acetate in patients receiving chemotherapy.

PURPOSE: Several trials had independently noted that patients receiving megestrol acetate had less nausea and vomiting, but this antiemetic activity of megestrol acetate has not been reported separately in the literature. Our objective was to evaluate the antiemetic ability of megestrol acetate in patients receiving chemotherapy. PATIENTS AND METHODS: Patients receiving chemotherapy were randomly assigned to receive either megestrol acetate 320 mg PO or placebo before the first day of chemotherapy, followed on days 1-4 by megestrol acetate 320 mg PO combined with granisetron 3 mg IV and metoclopramide 20 mg IM or only granisetron 3 mg IV combined with metoclopramide 20 mg IM in a crossover manner during two consecutive cycles. Rates of complete protection against both vomiting and moderate-to-severe nausea was the primary end point. RESULTS: One hundred patients were enrolled in the study. The antiemetic regimen containing megestrol acetate was superior in providing complete protection from nausea and vomiting (45% megestrol acetate regimen vs.17% no megestrol acetate regimen). Complete response of acute phase in both antiemetic regimens was different (85% megestrol acetate regimen vs. 72% no megestrol acetate regimen). Complete response of delayed emesis was also different (49% megestrol acetate regimen vs. 18% no megestrol acetate regimen). Adverse events were mostly mild to moderate. There were no serious drug-related adverse events between the two antiemetic regimens. CONCLUSION: Megestrol acetate was shown to be an effective antiemetic agent. Megestrol acetate might be a new antiemetic option for chemotherapy.

Inhibition of ovulation by NOMAC/E2, a novel monophasic oral contraceptive combining nomegestrol acetate and 17ß-oestradiol: a double-blind, randomised, dose-finding pilot study.

OBJECTIVE: To explore the optimal dose of the progestogen, nomegestrol acetate (NOMAC), required in a monophasic oral contraceptive, in combination with 1.5 mg 17ß-oestradiol (E(2)), to inhibit ovulation. METHODS: A double-blind, randomised study assessing 41 normally cycling women (aged 18-35 years) over two screening cycles, one control cycle and one consecutive treatment cycle; 38 women completed the treatment period. Subjects received 0.625 mg NOMAC/1.5 mg E(2) (n = 9), 1.25 mg NOMAC/1.5 mg E(2) (n = 10), 2.5 mg NOMAC/1.5 mg E(2) (n = 10) or 2.5 mg NOMAC alone (n = 9) for 21 days. RESULTS: During the treatment cycle, ovulation was suppressed in all treatment groups. The lowest plasma E(2) levels were observed with 2.5 mg NOMAC given alone. Addition of 1.5 mg E(2) to 2.5 mg NOMAC resulted in statistically significant increases in E(2) levels and decreases in mean follicle-stimulating hormone and luteinising hormone levels. In the three NOMAC/E(2) combination groups, a statistically significant inverse correlation was found between E(2) plasma levels and NOMAC dose. CONCLUSION: The dose of 2.5 mg NOMAC was confirmed to be optimal to inhibit both ovulation and follicular maturation. The antigonadotropic effect of 2.5 mg NOMAC was reinforced when combined with 1.5 mg E(2).

[Analysis of the initial efficacy of nedaplatin combined with megestrol in concurrent chemoradiotherapy for advanced cervical cancer].

OBJECTIVE: To investigate the early efficacy of nedaplatin combined with megestrol in concurrent chemoradiotherapy for advanced cervical cancer. METHODS: Forty-two cases of cervical cancer (FIGO IIb to IVa) were divided randomly into two groups: radiotherapy alone (21 cases) and radiation plus chemotherapy (Nedaplatin) group. The same radiotherapy was given to the two groups. Patients of the RT + C group received nedaplatin 30 mg/m2 in intravenous drip infusion once weekly on day 1, for 4 to 5 weeks, and megestrol 160 mg orally every day during the radiation therapy. RESULTS: The early outcome: the complete remission rate was 81.0% and partial remission rate was 19.0% in the RT + C group, significantly better than the CR (38.1%) and PR (42.9%) in the RT group. The 1-year survival rates in the two groups were 100% (21/21) and 81.0% (17/21), respectively, with a significant difference between the two groups (P<0.05). CONCLUSIONS: The combination of nedaplatin and megestrol with concurrent chemoradiotherapy can improve the early outcome of advanced cervical cancer, with somewhat increased but tolerable adverse effects.

Pilot Data on the Feasibility And Clinical Outcomes of a Nomegestrol Acetate Oral Contraceptive Pill in Women With Premenstrual Dysphoric Disorder.

Background: Up to 80% of reproductive-aged women experience premenstrual symptoms. Premenstrual Dysphoric Disorder (PMDD) is a severe form, affecting 2-5% of women. Combined oral contraceptive pills (COCPs) are used in the treatment of PMDD. Clinical practice suggests that a newer COCP containing nomegestrol acetate (2.5mg) and 17-beta estradiol (1.5mg), may be a suitable treatment for mood symptoms in PMDD. Materials and Methods: This was a clinical follow-up feasibility study of women who had attended the Monash Alfred Psychiatry research centre, Women's Mental Health Clinic, with a diagnosis of PMDD. 67% of the sample also had concurrent cPTSD, 29% co-morbid anxiety, and 20% depression. They were recommended treatment with nomegestrol acetate/17-beta estradiol. Eligible women were contacted by telephone to answer a questionnaire to assess women's subjective response to nomegestrol acetate/17-beta estradiol, acceptability and the Depression, Anxiety and Stress Scale-21 (DASS-21) after being recommended nomegestrol acetate/17-beta estradiol. The paired-sample t-test was used to determine if there were any statistically significant differences in the DASS-21 scores over the study observation period (before and after taking nomegestrol acetate/17-beta estradiol). Results: 35 (74.5%) women reported a subjective positive mood response to nomegestrol acetate/17-beta estradiol, 31 (63.3%) adhered to the medication, and only 10 (20.4%) women reported side effects as the main reason for discontinuing nomegestrol acetate/17-beta estradiol. There were statistically significant reductions (p<0.05) in the overall DASS-21 scores from before women commenced nomegestrol acetate/17-beta estradiol and after commencement of treatment. Conclusions: This preliminary study supports the acceptability and effectiveness of nomegestrol acetate/17-beta estradiol as a treatment for mood symptoms in PMDD. Further research, particularly a randomized controlled trial, is required to elucidate the effect of nomegestrol acetate/17-beta estradiol treatment on mood in PMDD.

Does Nomegestrol Acetate Plus 17ß-Estradiol Oral Contraceptive Improve Endometriosis-Associated Chronic Pelvic Pain in Women?

Background: To evaluate the effects of a 24/4 regimen combined oral contraceptive (COC) containing 1.5 mg 17ß-estradiol (E2) and 2.5 mg nomegestrol acetate (NOMAC) compared to on-demand nonsteroidal anti-inflammatory drugs (NSAIDs) on women affected by endometriosis-associated chronic pelvic pain (the primary end point) and their quality of life (QoL) and sexual function (the secondary end points). Materials and Methods: Ninety-nine women on E2/NOMAC constituted the study group; and 63 women on NSAIDs constituted the control group. The visual analogic scale was used to measure the levels of pelvic pain, dysmenorrhea, and dyspareunia. To assess their QoL, sexual function, and sexual distress, the Short Form-36 (SF-36), the Female Sexual Function Index (FSFI), and the Female Sexual Distress Scale (FSDS) were used, respectively. The study included two follow-ups at 3 and 6 months. Results: Improvement in chronic pelvic pain was observed in the study group at both the 3- and 6-month follow-ups (p < 0.001). SF-36, FSFI, and FSDS had a similar trend at the 3- and 6-month follow-ups (p < 0.001). Women on NSAIDs did not report any reduction in pain symptoms or improvement in QoL (p ≤ 0.4). However, they had a limited improvement of their FSFI and FSDS (p < 0.001). The improvement of the pain symptoms, QoL, FSFI, and FSDS, was more evident in women on E2/NOMAC than in those on NSAIDs, when the study group and control group values were compared at the 3- and 6-month follow-ups (p < 0.001). Conclusions: Women on E2/NOMAC COC showed a better reduction of endometriosis-associated chronic pelvic pain and an improvement of their QoL and sexual activity than those of the women on NSAIDs.

The effectiveness of quick starting oral contraception containing nomegestrol acetate and 17-ß estradiol on ovulation inhibition: A randomized controlled trial.

To determine the effectiveness of quick starting combined oral contraception (COC) contain 2.5 mg nomegestrol acetate and 1.5 mg estradiol (NOMAC/E2) comparing with 0.075 mg gestodene and 0.02 mg ethinyl estradiol (GS/EE) on ovarian ovulation inhibition rate, we conducted a non-inferiority randomized controlled trial involving 69 healthy female volunteers aged 18-40 years who had normal menstrual history and were randomized at a 2:1 ratio to take one pack of COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9. The ovarian activity was assessed by using Hoogland and Skouby grading. Forty-six and 23 participants were randomized to NOMAC/E2 and GS/EE groups, respectively. Baseline characteristics were similar between groups. No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000). Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.

An open-label study of subdermal implants of estradiol-only versus subdermal implants of estradiol plus nomegestrol acetate: effects on symptom control, lipid profile and tolerability.

OBJECTIVE: To compare the effects of continuous 17-beta estradiol-only silastic implants with those of continuous 17-beta estradiol plus continuous nomegestrol acetate silastic implants on symptom control, lipid profile and tolerability in postmenopausal women. METHODS: This was an open-label, parallel-group study. Women with and without uterus and no contraindications to hormone therapy (HT) in this study, we consider as HT the replacement of Estrogens-only and Estrogens + Progestogens Therapy, were enrolled. Each subject was assigned to receive four 17-beta estradiol-only silastic implants (women without uterus), or four 17-beta estradiol plus one nomegestrol acetate silastic implant (women with intact uterus), for 1 year. RESULTS: A total of 40 subjects were enrolled and received, the silastic implants of which 40 (100.0%) subjects completed the study (n = 20, estradiol only; n = 20, estradiol plus nomegestrol acetate). The incidence of postmenopausal symptoms decreased significantly. No significant decreases in total cholesterol (1.3%), low-density lipoprotein cholesterol (1.1%), triglycerides (1.2%) and fasting glucose ((1.3%) serum levels were observed in both groups, whereas high-density lipoprotein (HDL) cholesterol increased significantly (2.8%), during the study in both groups. The incidences of adverse events were similar in both treatment groups. CONCLUSIONS: Women treated with 17-beta estradiol-only silastic implants or 17-beta estradiol plus nomegestrol acetate silastic implants showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms and a significant increase in HDL cholesterol and no significant differences in other lipid profiles and tolerability.

Fertility-preserving treatment of stage IA, well-differentiated endometrial carcinoma in young women with hysteroscopic resection and high-dose progesterone therapy.

OBJECTIVE: The standard treatment for endometrial cancer is surgery with hysterectomy. However, this procedure will cause infertility in young women who desire to preserve pregnant ability. Conservative management with hormone therapy has been shown to be satisfactory in both tumor control and fertility preservation. Recently, hysteroscopic tumor resection followed by progestin therapy has been reported to be an alternative strategy. In this study we present our experience with this approach. MATERIALS AND METHODS: Six young patients (30-36 years old) diagnosed with grade 1 stage IA endometrial cancer who wished to preserve fertility were enrolled for this treatment procedure. The patients underwent hysteroscopic tumor resection followed by oral progestin therapy with either megestrol acetate or medroxyprogesterone acetate for at least 6 months. Interval hysteroscopy with biopsy was performed during the treatment course to evaluate disease response. RESULTS: All of the six patients had complete tumor remission after hysteroscopic resection and progestin therapy (five in 6 months, one in 9 months). In a median follow-up of 32 months (range 4-49months), one patient became pregnant spontaneously and delivered a full-term healthy baby via cesarean section. She received a definite surgery 3 months later, and the pathology confirmed no tumor existence. The other five patients were also free of disease at the last follow-up. CONCLUSION: Hysteroscopic tumor resection followed by progestin therapy for early-stage and well-differentiated endometrial cancer is a safe conservative treatment strategy. It could be an option for young patients who wish to preserve fertility.