Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaginal progesterone 8% Vaginal progesterone application 8% |
Device: Vaginal progesterone 8%
vaginal self application
|
| Placebo Comparator: Placebo Oral multivitamin supplement |
Device: Vaginal progesterone 8%
vaginal self application
|
Outcome Measures
Primary Outcome Measures
- FSFI (Female Sexual Function Index) questionnaire "arousal" domain [1 month]
Increment
Secondary Outcome Measures
- FSFI (Female Sexual Function Index) questionnaire "lubrication" domain [1 month]
Increment
- FSFI (Female Sexual Function Index) questionnaire all domains [1 month]
Increment
- FSDS-R (Female Sexual Distress Scale- Revised) score [1 month]
Decline
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bezmialem Vakif University | Istanbul | Turkey | 34093 |
Sponsors and Collaborators
- Bezmialem Vakif University
Investigators
- Principal Investigator: Serdar G Aydin, M.D, Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
Study Documents (Full-Text)
None provided.More Information
Publications
- Brown SG, Calibuso MJ, Roedl AL. Women's sexuality, well-being, and the menstrual cycle: methodological issues and their interrelationships. Arch Sex Behav. 2011 Aug;40(4):755-65. doi: 10.1007/s10508-010-9630-3. Epub 2010 May 13.
- Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425. Review.
- Grebe NM, Gangestad SW, Garver-Apgar CE, Thornhill R. Women's luteal-phase sexual proceptivity and the functions of extended sexuality. Psychol Sci. 2013 Oct;24(10):2106-10. doi: 10.1177/0956797613485965. Epub 2013 Aug 21.
- Prasad A, Mumford SL, Buck Louis GM, Ahrens KA, Sjaarda LA, Schliep KC, Perkins NJ, Kissell KA, Wactawski-Wende J, Schisterman EF. Sexual activity, endogenous reproductive hormones and ovulation in premenopausal women. Horm Behav. 2014 Jul;66(2):330-8. doi: 10.1016/j.yhbeh.2014.06.012. Epub 2014 Jun 20.
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