NCT02968342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

November 16, 2016

Last Update Submit

October 19, 2017

Conditions

MenopauseSexual Desire DisorderHypoactive Sexual Desire Disorder

Keywords

Hypoactive sexual desire disorder

Outcome Measures

Primary Outcomes (1)

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

    Increment

    1 month

Secondary Outcomes (3)

  • FSFI (Female Sexual Function Index) questionnaire "lubrication" domain

    1 month

  • FSFI (Female Sexual Function Index) questionnaire all domains

    1 month

  • FSDS-R (Female Sexual Distress Scale- Revised) score

    1 month

Study Arms (2)

Vaginal progesterone 8%

EXPERIMENTAL

Vaginal progesterone application 8%

Device: Vaginal progesterone 8%

Placebo

PLACEBO COMPARATOR

Oral multivitamin supplement

Device: Vaginal progesterone 8%

Interventions

Vaginal progesterone 8%DEVICE

vaginal self application

PlaceboVaginal progesterone 8%

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal status
  • Sexually active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24954690BACKGROUND

  • 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.

    PMID: 20464468BACKGROUND

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

    PMID: 18252670BACKGROUND

  • 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.

    PMID: 23965377BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Serdar G Aydin, M.D

    Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe G Karasu, M.D

CONTACT

5365144142agokmenkarasu@bezmialem.edu.tr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

TU(1)