Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Phase 4

• Conditions: Menopause; Hypoactive Sexual Desire Disorder; Sexual Desire Disorder
• Interventions: Device: Vaginal progesterone 8%

• Registration Number: NCT02968342
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

The objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. Half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.

Detailed Description

Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to hormone concentrations and ovulation in women. Women's sexuality, unlike that of most mammals, is not solely defined by sexual receptivity during the short window of fertility. Women are also prone to initiate luteal-phase sex when serum levels of progesterone are highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause women may face alterations in sexual desire.

The role of progesterone supplementation in improving sexual desire in the menopausal period is investigated.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Menopausal status
• Sexually active

Exclusion Criteria

• Medical history of chronic psychiatric disease
• Medical conditions associated with female sexual dysfunction; cardiovascular disease, uncontrolled chronic HT (hypertension) ,DM (diabetes mellitus), History of gynecologic surgery, female gynecological cancer ( breast, ovarian, uterine, cervical)
• Medications associated with female sexual dysfunction; Antidepressants opiates, beta blockers, Antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone 8%	Vaginal progesterone 8%	Vaginal progesterone application 8%
Placebo	Vaginal progesterone 8%	Oral multivitamin supplement

Primary Outcome Measures

Name	Time	Method
FSFI (Female Sexual Function Index) questionnaire "arousal" domain	1 month	Increment

Secondary Outcome Measures

Name	Time	Method
FSDS-R (Female Sexual Distress Scale- Revised) score	1 month	Decline
FSFI (Female Sexual Function Index) questionnaire "lubrication" domain	1 month	Increment
FSFI (Female Sexual Function Index) questionnaire all domains	1 month	Increment

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey