Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Conditions
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Menopause, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Device: Vaginal progesterone 8%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal progesterone 8%<br>Vaginal progesterone application 8% | Device: Vaginal progesterone 8%<br>* vaginal self application<br>|
| Placebo Comparator: Placebo<br>Oral multivitamin supplement | Device: Vaginal progesterone 8%<br>* vaginal self application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSFI (Female Sexual Function Index) questionnaire arousal domain | Increment | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSFI (Female Sexual Function Index) questionnaire lubrication domain | Increment | 1 month | 
| FSFI (Female Sexual Function Index) questionnaire all domains | Increment | 1 month | 
| FSDS-R (Female Sexual Distress Scale- Revised) score | Decline | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoactive sexual desire disorder