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NCT02968342 Clinical Trial

Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Menopause Clinical Trial

Official title:
Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02968342
Other study ID # 18.11.2015-21/35
Secondary ID
Status Recruiting
Phase Phase 4
First received November 16, 2016
Last updated October 19, 2017
Start date July 2016
Est. completion date July 2018

Study information
Verified date October 2017
Source Bezmialem Vakif University
Contact Ayse G Karasu, M.D
Phone 5365144142
Email agokmenkarasu@bezmialem.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Vaginal progesterone 8%
vaginal self application

Locations
Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425. Review. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary FSFI (Female Sexual Function Index) questionnaire "arousal" domain Increment 1 month
Secondary FSFI (Female Sexual Function Index) questionnaire "lubrication" domain Increment 1 month
Secondary FSFI (Female Sexual Function Index) questionnaire all domains Increment 1 month
Secondary FSDS-R (Female Sexual Distress Scale- Revised) score Decline 1 month
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