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A pilot study to investigate the role of androgens in the sexual functioning of women with primary ovary insufficiency (POI).


- candidate number8619
- NTR NumberNTR2585
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-nov-2010
- Secondary IDs 
- Public TitleA pilot study to investigate the role of androgens in the sexual functioning of women with primary ovary insufficiency (POI).
- Scientific TitleA pilot study to investigate the role of androgens in the sexual functioning of women with primary ovary insufficiency (POI).
- ACRONYMPOI-study
- hypothesisWomen with POI have low androgen blood levels which leads to less overall sexual satisfaction, less frequent desire and more pain during sex.
- Healt Condition(s) or Problem(s) studiedSexual dysfunction, Primary Ovarian Insufficiency (POI)
- Inclusion criteria1. Participating in the POI-trial in Utrecht;
2. Being treated for POI at the AMC, Amsterdam.
- Exclusion criteria1. Oophorectomy;
2. Severe relationship problems.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 26-nov-2010
- planned closingdate
- Target number of participants10
- InterventionsN/A
- Primary outcomeHormone levels:
1. Estradiol;
2. Total testosterone;
3. Bio-available testosterone;
4. SHBG;
5. Androstenedione;
6. Dehydroepiandrosterone sulfate.

Sexual function:
1. Genital response by VPA;
2. Subjective response by questionnaires, FSFI & FSDS-R.

Implicit association tasks:
1. stIAT;
2. PAT;
3. Dot detection task.
- Secondary outcomeThe feasibility of these tests in this group, measured by interview.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Sarah Coppes
- CONTACT for SCIENTIFIC QUERIES Sarah Coppes
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD4-nov-2010 - 13-nov-2010


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