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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02968342 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
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Scientific title:
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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02968342 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Ayse G Karasu, M.D |
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Address:
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Telephone:
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5365144142 |
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Email:
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agokmenkarasu@bezmialem.edu.tr |
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Affiliation:
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Name:
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Ayse F Karasu |
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Address:
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Telephone:
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5365144142 |
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Email:
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agokmenkarasu@bezmialem.edu.tr |
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Affiliation:
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Name:
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Serdar G Aydin, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bezmialem Üniversitesi Tip Fakültesi Hastanesi |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sexual Desire Disorder
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Menopause
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Hypoactive Sexual Desire Disorder
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Intervention(s)
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Device: Vaginal progesterone 8%
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Primary Outcome(s)
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FSFI (Female Sexual Function Index) questionnaire "arousal" domain
[Time Frame: 1 month]
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Secondary Outcome(s)
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FSFI (Female Sexual Function Index) questionnaire "lubrication" domain
[Time Frame: 1 month]
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FSDS-R (Female Sexual Distress Scale- Revised) score
[Time Frame: 1 month]
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FSFI (Female Sexual Function Index) questionnaire all domains
[Time Frame: 1 month]
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Secondary ID(s)
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18.11.2015-21/35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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