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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

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ClinicalTrials.gov Identifier: NCT02968342
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Menopause Sexual Desire Disorder Hypoactive Sexual Desire Disorder Device: Vaginal progesterone 8% Phase 4

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




Primary Outcome Measures :
  1. FSFI (Female Sexual Function Index) questionnaire "arousal" domain [ Time Frame: 1 month ]
    Increment


Secondary Outcome Measures :
  1. FSFI (Female Sexual Function Index) questionnaire "lubrication" domain [ Time Frame: 1 month ]
    Increment

  2. FSFI (Female Sexual Function Index) questionnaire all domains [ Time Frame: 1 month ]
    Increment

  3. FSDS-R (Female Sexual Distress Scale- Revised) score [ Time Frame: 1 month ]
    Decline



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968342


Contacts
Contact: Ayşe G Karasu, M.D 5365144142 agokmenkarasu@bezmialem.edu.tr

Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Turkey, 34093
Contact: Ayşe F Karasu    5365144142    agokmenkarasu@bezmialem.edu.tr   
Contact: Ayşe F Karasu, Türkiye    5365144142 ext Karasu    agokmenkarasu@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Principal Investigator: Serdar G Aydin, M.D Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

Publications:
Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT02968342     History of Changes
Other Study ID Numbers: 18.11.2015-21/35
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bezmialem Vakif University:
Hypoactive sexual desire disorder

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Disease
Hypokinesia
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs