Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

October 19, 2017 updated by: Bezmialem Vakif University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSFI (Female Sexual Function Index) questionnaire "arousal" domain
Time Frame: 1 month
Increment
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
Time Frame: 1 month
Increment
1 month
FSFI (Female Sexual Function Index) questionnaire all domains
Time Frame: 1 month
Increment
1 month
FSDS-R (Female Sexual Distress Scale- Revised) score
Time Frame: 1 month
Decline
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Serdar G Aydin, M.D, Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.11.2015-21/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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