Sexual dysfunction caused by the use of oral contraceptives MedDRA version: 9.1 Level: LLT Classification code 10057671 Term: Female sexual dysfunction
Conditions
Interventions
Product Name: dehydroepiandrosterone (DHEA)
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Pantarhei Bioscience BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women using OC 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 (MMQ General Marital Satisfaction scale score = 10). Partner is expected to be physically present at least 50% of each month for the duration of the study 3. Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs 4. Report of decline in sexual desire and or responsivity, and attributing this to OC use as evidenced by an FSFI Sexual desire scale score > 2.6 and an in depth interview 5. Regular menstrual cycles (24-35 days) prior to last start of OC use 6. Body mass index between (=) 18 and (=) 35 kg/m2 7. Non-depressed women, BDI-II Beck’s Depression Inventory score (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Androgen therapy during the 6 months prior to screening 2. Use of non-oral hormonal contraception in the 3 months prior to screening 3. Intention to become pregnant during the study 4. Lactation and/or pregnancy in the previous 6 months prior to screening 5. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening 6. Depression, BDI-II Beck’s Depression Inventory score (=) 14 7. Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory and physical examination and vital signs 8. Contraindications for contraceptive steroids: 9. 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, nelfinavir, ritonavir and St. John’s wort (Hypericum perforatum) 10. 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 OC users on: • the degree of sexual desire as measured by a single item: ‘To what extent did you feel like having sex in the past 24 hours?’;Secondary Objective: • To determine the frequency of sexual desire over past 3 weeks of OC intake measured with item 4 from the Sexual Interest and Desire Inventory-Female (SIDI-F) • To determine the ease of sexual arousal (responsivity) over past 3 weeks of OC intake measured with item 11 from the Sexual Interest and Desire Inventory-Female (SIDI-F) • To determine the frequency of satisfying sexual events measured by the Sexual Event Log (SEL) • Satisfaction and health related quality of life measured by the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire ;Primary end point(s): The degree of sexual desire as measured by a single item: ‘To what extent did you feel like having sex in the past 24 hours?’ This is a daily rating included in the Study Diary. | — |
Countries
Netherlands
Outcome results
None listed