ISRCTN03247616
Completed
Phase 2
A double-blind, placebo controlled, randomised, comparative 2-way crossover study to determine the effect of concomitant treatment with an androgen on sexual arousability and the vascular component of the sexual arousal response during self-induced erotic fantasy and visual stimulation in women using oral contraception
Pantarhei Bioscience BV (Netherlands)0 sites81 target enrollmentDecember 21, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pantarhei Bioscience BV (Netherlands)
- Enrollment
- 81
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29490289 (added 14/10/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy females between 20 and 35 years of age
- •2\. Using OC for at least three consecutive cycles prior to screening
- •3\. Stable, heterosexual relationship for at least 3 months prior to screening
- •4\. Willing to interrupt OC use for a period of 4 weeks
- •5\. Regular menstrual cycle (24 \- 35 days) prior to last start of OC use
- •6\. Body mass index (BMI) between (greater than or equal to) 18 and (less than or equal to) 35 kg/m^2
- •7\. Good physical and mental health
- •8\. Sign a written informed consent agreement
Exclusion Criteria
- •1\. Maudsley Marital Questionnaire (MMQ) General Marital Satisfaction Scale Score greater than or equal to 20; Symptoms Checklist\-90 (SCL\-90\) Depression Scale score greater than or equal to 28; SCL\-90 Anxiety Scale Score greater than or equal to 18
- •2\. Hormonal contraception use during the 1 cycle prior to the start study medication
- •3\. Use of non\-oral hormonal contraception in the 3 months prior to the screening
- •4\. Total T value greater than 5 nmol/L at time of screening or at the pre\-test vaginal photoplethysmograph (VPP) session
- •5\. Androgen therapy during the 6 months prior to screening
- •6\. Intention to become pregnant during the study
- •7\. Lactation and/or pregnancy in the previous 6 months prior to screening
- •8\. Any clinically significant abnormality following review of medical history, laboratory results and physical examination at screening
- •9\. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening
- •10\. Use of one or more of the following medications: psychoactive drugs, anti\-hypertensive drugs, sex steroids other than the current OC
Outcomes
Primary Outcomes
Not specified
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