In postmenopausal women with low bone mass, denosumab increased bone mineral density and decreased bone resorption. These preliminary data suggest that denosumab might be an effective treatment for osteoporosis. (ClinicalTrials.gov number, NCT00043186.).

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This study is an evaluation of surgical treatment for vulvar vestibulitis, a major cause of superficial dyspareunia in premenopausal women. Its estimated prevalence in a general gynecologic population is 15%. Those affected have severe vestibular pain on touch or vaginal entry as well as tenderness to pressure within the vulvar vestibule. It is not uncommon for symptoms to last longer than 6 months with no apparent cause. The investigators reviewed the records of 155 women 40 years of age or younger who were operated on for this condition in the years 1998 through 2001. Just over 80% of these women (n ϭ 126) were interviewed by telephone 1 to 4 years postoperatively.A single gynecologist performed all operations in a uniform manner under general anesthesia on an outpatient or short-admission setting. Vestibulectomy and advancement plasty are carried out. The procedure entails total removal of the hymen and the full thickness of skin on the adjacent vestibulum (Hart's line and the fourchette are boundaries). The remaining defect is covered by vaginal wall after it has been undermined and advanced. Vaginal dilation exercises with a mold begin 6 weeks postoperatively if wound healing is satisfactory; at the same time, women are encouraged to begin or resume intercourse.The phone interview, carried out a median of 37 months after surgery, revealed that 93% of women were able to have intercourse and that 62% had no pain in doing do. Just over 60% of women had no postoperative complications. The most common problem, affecting approximately one fourth of patients, was decreased lubrication during sexual arousal. Eight patients (6%) developed a Bartholin's cyst. The odds ratio (OR) for being able to have intercourse only after surgery was 3.43 (95% confidence interval [CI], 1.48-7.96). For women 30 years of age or younger, the OR was 8.20 (95% CI, 1.54-43.73). Younger women were especially disposed to suggest the procedure to other patients. The results were basically the same after adjusting ORs for the follow-up interval. The outcome of surgery could not be related to parity, the ability to have intercourse before surgery, or previous nonsurgical treatment.Surgery has a role in the management of vulvar vestibulitis syndrome; and, because there is a low risk of surgical complications, it can be presented as a potentially helpful option when medical measures have proved not to be effective. GYNECOLOGYVolume 61, Number 6 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACT Although laparoscopic myomectomy (LM) provides a minimally invasive alternative to laparotomy for removing intramural and subserosal uterine myomas, even experienced surgeons occasionally have to convert to an open procedure. Dubuisson and coworkers have developed a model predicting the need for laparoconversion (LC) based on 4 independent risk factors: size, type, and site of the dominant myoma, and pretreatment with a gonadotropin-releasing hormone agonist. The investigators sought to identify preoperative factors that influence the need for LC in 116 women ...

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Objective: Menopausal vasomotor symptoms (VMS) may result from altered thermoregulatory control in brain regions innervated by neurokinin 3 receptor-expressing neurons. This phase 2b study evaluated seven dosing regimens of fezolinetant, a selective neurokinin 3 receptor antagonist, as a nonhormone approach for the treatment of VMS. Methods: Menopausal women aged >40-65 years with moderate/severe VMS (≥50 episodes/wk) were randomized (double-blind) to fezolinetant 15, 30, 60, 90 mg BID or 30, 60, 120 mg QD, or placebo for 12 weeks. Primary outcomes were reduction in moderate/severe VMS frequency and severity ([number of moderate VMS × 2] + [number of severe VMS × 3]/total daily moderate/severe VMS) at weeks 4 and 12. Response (≥50% reduction in moderate/severe VMS frequency) was a key secondary outcome. Results: Of 352 treated participants, 287 completed the study. Fezolinetant reduced moderate/severe VMS frequency by −1.9 to −3.5/day at week 4 and −1.8 to −2.6/day at week 12 (all P < 0.05 vs placebo). Mean difference from placebo in VMS severity score was −0.4 to −1 at week 4 (all doses P < 0.05) and −0.2 to −0.6 at week 12 (P < 0.05 for 60 and 90 mg BID and 60 mg QD). Response (50% reduction) relative to placebo was achieved by 81.4% to 94.7% versus 58.5% of participants at end of treatment (all doses P < 0.05). Treatment-emergent adverse events were largely mild/moderate; no serious treatment-related treatment-emergent adverse events occurred. Conclusions: Fezolinetant is a well-tolerated, effective nonhormone therapy that rapidly reduces moderate/severe menopausal VMS. Video Summary: http://links.lww.com/MENO/A572; video script available at http://links.lww.com/MENO/A573.

Objective: In the primary analysis of the phase 2b VESTA study, oral fezolinetant reduced frequency and severity of menopausal vasomotor symptoms (VMS) compared with placebo. This secondary analysis evaluates effects of fezolinetant on responder rates and patient-reported outcomes (PROs). Methods: In this 12-week, double-blind study, postmenopausal women with moderate/severe VMS were randomized to fezolinetant 15, 30, 60, or 90 mg BID or 30, 60, or 120 mg QD or placebo. Proportion of responders was based on reductions in VMS from daily diary records. P values for comparisons between active treatment and placebo were calculated using logistic regression. Changes from baseline in PROs (Menopause-Specific Quality of Life questionnaire, Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale) were conducted using a mixed model for repeated measurements and compared post hoc with published minimally important differences (MIDs). Results: Of 356 women randomized, 352 were treated and analyzed. A greater proportion of women receiving fezolinetant versus placebo met definitions of response at week 12. For all doses, mean changes from baseline in Menopause-Specific Quality of Life questionnaire VMS scores exceeded the MID (1.2) at weeks 4 (placebo: −1.8; fezolinetant: range, −1.9 to −3.6) and 12 (placebo: −2.3; fezolinetant: range, −2.9 to −4.4). Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: −2.2; fezolinetant: range, −2.5 to −3.8) and 12 (placebo: −2.9; fezolinetant: range, −3.3 to −4.3) exceeded the MID (1.76). Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: −1.7; fezolinetant: range, −2.1 to −3.3; week 12, placebo: −2.1; fezolinetant: range, −2.7 to −3.6). Conclusions: Oral fezolinetant was associated with higher responder rates than placebo and larger improvements in QoL and other PRO measures, including a reduction in VMS-related interference with daily life.

SKYLIGHT 4 (Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause) demonstrates the 52-week safety and tolerability of fezolinetant and its use for the treatment of vasomotor symptoms associated with menopause.

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