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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Primary Purpose

Menopause, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Vaginal progesterone 8%
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring Hypoactive sexual desire disorder

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal progesterone 8%

Placebo

Arm Description

Vaginal progesterone application 8%

Oral multivitamin supplement

Outcomes

Primary Outcome Measures

FSFI (Female Sexual Function Index) questionnaire "arousal" domain
Increment

Secondary Outcome Measures

FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
Increment
FSFI (Female Sexual Function Index) questionnaire all domains
Increment
FSDS-R (Female Sexual Distress Scale- Revised) score
Decline

Full Information

First Posted
November 16, 2016
Last Updated
October 19, 2017
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT02968342
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder
Keywords
Hypoactive sexual desire disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaginal progesterone 8%
Arm Type
Experimental
Arm Description
Vaginal progesterone application 8%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral multivitamin supplement
Intervention Type
Device
Intervention Name(s)
Vaginal progesterone 8%
Intervention Description
vaginal self application
Primary Outcome Measure Information:
Title
FSFI (Female Sexual Function Index) questionnaire "arousal" domain
Description
Increment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
Description
Increment
Time Frame
1 month
Title
FSFI (Female Sexual Function Index) questionnaire all domains
Description
Increment
Time Frame
1 month
Title
FSDS-R (Female Sexual Distress Scale- Revised) score
Description
Decline
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe G Karasu, M.D
Phone
5365144142
Email
agokmenkarasu@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar G Aydin, M.D
Organizational Affiliation
Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayşe F Karasu
Phone
5365144142
Email
agokmenkarasu@bezmialem.edu.tr
First Name & Middle Initial & Last Name & Degree
Ayşe F Karasu, Türkiye
Phone
5365144142
Ext
Karasu
Email
agokmenkarasu@bezmialem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24954690
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.
Results Reference
background
PubMed Identifier
20464468
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.
Results Reference
background
PubMed Identifier
18252670
Citation
Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425.
Results Reference
background
PubMed Identifier
23965377
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.
Results Reference
background

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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

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