Effect of concomitant treatment with an androgen on sexual functioning in women using an oral contraceptio

Phase 2

Completed

• Conditions: Hormonal anticonception; Pregnancy and Childbirth

• Registration Number: ISRCTN03247616
• Lead Sponsor: Pantarhei Bioscience BV (Netherlands)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29490289 (added 14/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-07-01
• Study Start: 2009-12-21
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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
11. Present use or use within 30 days before the start of the study medication of the following drugs: hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St John's wort (Hypericum perforatum)
12. Administration of any other investigational drug within 3 months prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Sexual arousability, sexual desire, and frequencies of sexual fantasies as assessed with the sexual function diary completed during the last two treatment cycle of each treatment period; each treatment period consists of 5 treatment cycles (each cycle: 28 days)<br> 2. Sexual function as assessed with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R), at screening, pretest, study visit at end of each treatment period<br> 3. Vaginal pulse amplitude (VPA) during sexual stimulation and experience of sexual arousal during sexual stimulation, at pretest visit, study visit at end of each treatment period<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Androgen parameters, measured at screening, pretest visit, study visit at end of each treatment period<br> 2. Daily hassles, completed during the last two treatment cycles of each treatment period<br> 3. Health diary, completed during the last two treatment cycles of each treatment period<br> 4. Haemostasis metabolism, measured at screening, pretest visit, study visit at end of each treatment period<br> 5. Bleeding data, measured with diary keeping during both treatment periods<br> 6. Safety assessment, measured throughout the study<br>