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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal progesterone 8% | Experimental | Vaginal progesterone application 8% |
|
| Placebo | Placebo Comparator | Oral multivitamin supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal progesterone 8% | Device | vaginal self application |
|
| Measure | Description | Time Frame |
|---|---|---|
| FSFI (Female Sexual Function Index) questionnaire "arousal" domain | Increment | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| FSFI (Female Sexual Function Index) questionnaire "lubrication" domain | Increment | 1 month |
| FSFI (Female Sexual Function Index) questionnaire all domains | Increment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayşe G Karasu, M.D | Contact | 5365144142 | agokmenkarasu@bezmialem.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Serdar G Aydin, M.D | Bezmialem Üniversitesi Tıp Fakültesi Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24954690 | Background | 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. | |
| 20464468 | Background |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 1 month |
| FSDS-R (Female Sexual Distress Scale- Revised) score | Decline | 1 month |
| 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. |
| 18252670 | Background | Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425. |
| 23965377 | Background | 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. |