Clinical trial NCT02968342: Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
Official title: Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Menopause
Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Keywords: Hypoactive sexual desire disorder
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: FSFI (Female Sexual Function Index) questionnaire "arousal" domain
timeFrame: 1 month
Secondary outcomes:
measure: FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
timeFrame: 1 month
measure: FSFI (Female Sexual Function Index) questionnaire all domains
timeFrame: 1 month
measure: FSDS-R (Female Sexual Distress Scale- Revised) score
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
name: Serdar G Aydin, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425.
citation: 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.