Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period.

OBJECTIVE: To compare the effects of a 12-week treatment with 17ss-estradiol given alone and in sequential combination with 3.75 mg of nomegestrol acetate (Naemis), or a placebo on biochemical markers of bone turnover in menopausal women. PATIENTS AND METHODS: A double-blind, randomized, placebo and estradiol-controlled multicenter study was conducted. A total of 176 patients who had been menopausal for 1-10 years, hysterectomized or not, having no contraindications to hormone replacement therapy, without any risks factors for osteoporosis, received one of these treatments during 12 weeks: placebo, 1.5 mg estradiol (E(2)) or 1.5 mg E(2)/3.75 mg nomegestrol acetate (E(2)/NOMAC). The primary efficacy variables were the change in bone markers (total alkaline phosphatase, bone alkaline phosphatase and osteocalcin; urinary type-I collagen peptides). RESULTS: The four biochemical markers decreased only in the E(2)/NOMAC group. Bone alkaline phosphatase, osteocalcin and urinary type-I collagen peptides decreased in the E(2) group. For both active treatment groups compared to the placebo group, the changes were statistically significant after a 12-week treatment. There were no statistically significant differences between the E(2) and the E(2)/NOMAC groups except for total serum alkaline phosphatase, whose mean value decreased in the E(2)/NOMAC group but increased slightly in the E(2) group (p < 0.001). Furthermore, after a 6-week treatment, the changes in biochemical markers of bone turnover were similar to those found after 12 weeks. Safety data were satisfactory with regard to estradiol given alone or in combination with nomegestrol acetate. CONCLUSION: These results demonstrated that 1.5 mg E(2) is effective in reducing bone turnover in postmenopausal women and proved that the combination of 1.5 mg E(2) and 3.75 mg nomegestrol acetate has no deleterious effect on bone remodelling.

[Acceptability of continuous combined versus cyclical HRT: a French multicentric randomized clinical study]. / Acceptabilité par les patientes d'un THS combiné continu versus cyclique: une étude clinique randomisée multicentrique française.

OBJECTIVES: To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiène (estradiol valerate 2 mg/dienogest 2 mg) or cyclic Climène (estradiol valerate 2 mg, from D1 to D21/cyproterone acetate 1 mg, from D12 to D21, followed by 7 days off), switching from previous sequential estroprogestative HRT because of side effects. PATIENTS AND METHODS: One hundred forty three postmenopausal women aged 54.39-years were recruited and randomised to Climène (N=68) or Climodiène (N=75). Acceptability was evaluated by the continuation rate in the 2 groups at the end of the 12 cycles study. Assessment of quality of life was obtained from the responses to the women's health questionnaire (WHQ) and to an ad hoc satisfaction questionnaire at baseline, and at the 12th cycle of treatment. RESULTS: No significant difference in baseline characteristics of volunteers were found in the 2 treatment groups except for the socioeconomic status (more town-dwellers in Climène group). Total WHQ score significantly improved after 12 months of treatment with Climène and Climodiène, respectively decreasing from 68.9 to 64.37 (-4.53) and from 69.95 to 62.06 (-7.89), with a trend towards higher improvement with Climodiène, particularly in the hot flushes subscale. In Climodiène group, a significant decrease in sleep problems and cognitive function subscales was found, which is consistent with previous polysomnography and psycho physiological measures data with Climodiène. The evolution of Satisfaction Index is positive and of the same magnitude in the 2 groups, showing an improvement at 12 months: respectively -2.79 (P=0.002) et -2.26 (P=0.02) for Climène and Climodiène. DISCUSSION AND CONCLUSIONS: Even though the benefit/risk ratio of the hormonal substitutive treatment is recognized effective against climateric symptoms which affect the quality of life, this work is the first randomised prospective study on the effects of Climodiène on quality of life in post-menopausal women assessed by the French validated version of the world-wide used WHQ. Decreases in "sleep problems" and "cognitive function" subscales scores in this study are of a magnitude clinically relevant and consistent with previous data on Climodiène impact on postmenopausal symptoms.

[Vulvovaginitis]. / Vulvo-vaginites.

Candidiasis, infection due to Trichomonas vaginalis and bacterial vaginosis (Gardnerella vaginalis and/or other species) represent the major three causes of vulvo-vaginitis. Other are rare bacterial infections and non infectious vaginitis such as allergic and post-menopausal vaginitis with epithelial atrophy. Clues for the diagnosis include the clinical features of vaginal discharge, cytological examinations, bacterial and fungal cultures. Only T. vaginalis seems to be responsible of sexually transmitted disease. All appropriate antibacterial or anticandidosic treatment are immediately effective, but the mechanisms of recurrent candidiasis and vaginosis are still unclear.

[Choice and follow-up of contraception without risk factor]. / Choix et surveillance d'une contraception en l'absence de facteur de risque.

Every young healthy and truly informed woman may use any contraceptive method. Teenagers have to avoid not only pregnancy but also AIDS and other sexually transmitted diseases. Therefore they may use condoms when aware of postcoital contraception or must use both condoms and oral contraceptives. Non smoker women over 40 may choose between combined oral contraceptives, high doses progestogens or IUDs. Whatever the age, newer preparations with desogestrel, norgestimate or gestodene will be preferentially used due to the absence of clinical and metabolic side-effects. Smokers before 35, nonsmoker women over 35 will be preferentially given pills with only 20 micrograms ethinyloestradiol.

Induction of amenorrhea during hormone replacement therapy: optimal micronized progesterone dose. A multicenter study.

The effects of oral micronized progesterone on the endometrium and bleeding pattern have been assessed in a multicenter study of 101 postmenopausal patients. During a minimum of 6 cycles, the participants received either percutaneous 17 beta-estradiol (1.5 mg/day) associated with micronized progesterone (100 mg/day), given at bedtime for 21/28 days or 25 days/calendar month (n = 98) [1], or E2 (3 mg/day) for 25 days associated with progesterone (300 mg/day), from day 16 to day 25 (n = 3) [2], according to their willingness to induce, or not, cyclic withdrawal bleeding. Each endometrial biopsy performed at 6-month minimum was assessed by two independent pathologists: results showed 61% quiescent without mitosis, 23% mildly active with very rare mitoses and 8% partial secretory endometrium. The remaining biopsies showed inadequate tissue (4%) or a sub-atrophy (4%). No hyperplasia was found by any pathologist. In the case of inadequate material, the mean thickness of endometrial mucosa measured by ultrasonography was 3.9 mm. Amenorrhea incidence was 93.3 and 91.6% at the 3rd and 6th month of therapy, respectively. No bleeding occurred in more than 80% of women. The results show that a low dose of oral progesterone (100 mg/day), given during 25 days, efficiently protects the endometrium by fully inhibiting mitoses and induces amenorrhea in the majority of postmenopausal women, allowing better compliance to long-term therapy.

[Hormonal assessment in a woman with acne and alopecia]. / Bilan hormonal chez une femme présentant une acné ou une alopécie.

Acne, androgenogenetic alopecia, hyperseborrhea and hirsutism may result from hyperandrogenism in women. This may be peripheral "idiopathic" hyperandrogenism due to cutaneous metabolism of steroids, but in some cases hyperandrogenism is due to abnormal production or input of steroids with androgenic activity (hyperplasia, endocrine tumors, cysts, consumption of progestogens or other hormones with androgenic activity, menopause...). An assessment is useful only in cases of acne or alopecia if they are accompanied by other signs of peripheral hyperandrogenism and/or disturbed menstruation. The treatment is based on the administration of an anti-androgen (in France, usually cyproterone acetate), combined with other local or systemic treatments for the problem, depending on the age, dermatological signs and context.

[Purified FSH in small doses. Is this not the best current treatment of polycystic ovaries resistant to clomid? 73 cycles]. / FSH purifiée à petites doses. N'est-ce pas la meilleure thérapeutique actuelle des ovaires polykystiques résistant au Clomid? A propos de 73 cycles.

Sixteen infertile women with the Polycystic ovary syndrome were treated using stimulation of ovulation with purified FSH after Clomid had failed. We compared the results of giving a short course (19 cycles) with giving a long course (54 cycles). With the long course there were fewer cases of hyperstimulation--2 out of 54 cycles (3.70%) as against 1 in 19 cycles with a short course (5.26%). There were fewer changes in the programme needed--6 out of 54 cycles (3.7%) as against 7 cycles out of 19 (31.57%). Ovulatory cycles occurred more frequently in 46 out of 54 cycles (85.18%) as against 12 out of 19 (63.15%). In the long courses 14 pregnancies out of 46 ovulatory cycles occurred (30.43%) as against 3 pregnancies out of 12 cycles (25%). The level of successful pregnancy was much higher in couples who had no other sterility factors--85.10% for the long course as against 63.15% for the short course. In summary purified FSH is an excellent treatment for ovarian dysfunction that is resistant to Clomid. It is necessary to have 3.41 ovulatory cycles to obtain a pregnancy. In this work there were no multiple pregnancies out of the 17 pregnancies and the 3 cases of hyperstimulation that were noted were moderate.