Sexual dysfunction caused by the use of oral contraceptives MedDRA version: 9.1 Level: LLT Classification code 10057671 Term: Female sexual dysfunction
Conditions
Interventions
Trade Name: Yasmin
Pharmaceutical Form: Film-coated tablet
Trade Name: Microgynon 30
Pharmaceutical Form: Coated tablet
Product Name: dehydroepiandrosterone (DHEA)
Pharmaceutical Form: Tablet
Pharma
Sponsors
Pantarhei Bioscience B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women using oral contraceptives for at least 3 months prior to screening and aged 20-35 years (inclusive) 2. Stable, heterosexual relationship for at least 3 months prior to screening 3. Willing to interrupt OC use for a period of 4 weeks and to use non-hormonal contraception prior to start study medication 4. Good physical and mental health as judged by the Investigator determined by medical history, physical examination, clinical laboratory and vital signs 5. Regular menstrual cycle (24-35 days) prior to last start of OC use 6. Body mass index between (=) 18 and (=) 35 kg/m2 7. Willing to give informed consent in writing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. MMQ General Marital Satisfaction scale score = 20; SCL-90 Depression scale score = 28; SCL-90 Anxiety scale score = 18 2. Total T > 5.0 nmol/l as measured at screening or at the pretest VPP session (i.e. around 14 days after start of withdrawal bleeding following discontinuation of OC use) 3. Androgen therapy during the 6 months prior to screening 4. Hormonal Contraception use during the 1 cycle prior to the start study medication 5. Use of non-oral hormonal contraception in the 3 months prior to the screening 6. Intention to become pregnant during the study 7. Lactation and/or pregnancy in the previous 6 months prior to screening 8. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening 9. Any clinically significant abnormality following review of medical history, pre-study laboratory data and physical examination 10. Contraindications for contraceptive steroids 11. Use of one or more of the following medications: - Psychoactive drugs - Antihypertensive drugs - Sex steroids other than the current OC - Use at present or within 30 days before start study medication: hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin and St. John’s wort (Hypericum perforatum) 12. Administration of any investigational drug within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of concomitant DHEA compared to placebo in the two treatment groups of OC users on: • Sexual arousability, levels of sexual desire, frequency of sexual fantasies assessed with a Sexual Function Diary (SFD) • Sexual function assessed with the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) • The vascular component of the sexual arousal response (VPA) determined by vaginal photoplethysmography (VPP) • Number of satisfying sexual events assessed with the SFD • Experience of sexual arousal during self-induced erotic fantasy (SEF) and visual sexual stimulation (VSS) ;Secondary Objective: • To determine the effect of concomitant DHEA on the frequency of and sexual response to sexual activities as assessed with the SFD • To investigate any correlation between VPA and subjective self-assessment measures of the sexual arousal response (SSAQ) • To determine the endocrinologic-sexual response relationship of concomitant DHEA • To evaluate the safety and tolerance of OC use with concomitant DHEA • To compare pretest sexual function (as determined by VPP assessments, SFD, FSFI and FSDS) with that of the two treatment periods ;Primary end point(s): 1. Sexual arousability, sexual desire, and frequencies of sexual fantasies (responsivity to sexual stimuli) as assessed with the SFD 2. Sexual function as assessed with the FSFI and FSDS 3. VPA during sexual stimulation 4. Experience of sexual arousal during sexual stimulation | — |
Countries
Netherlands
Outcome results
None listed