A double-blind, placebo controlled, randomised, comparative 2-way crossover study to determine the effect of concomitant treatment with dehydroepiandrosterone (50 mg) on sexual arousability and the vascular component of the sexual arousal response during self-induced erotic fantasy and visual sexual stimulation in women using oral contraception (150 mcg levonorgestrel and 30 mcg ethinylestradiol or 3 mg drospirenone and 30 mcg ethinylestradiol) - ARC study

Phase 1

• Conditions: Sexual dysfunction caused by the use of oral contraceptives; MedDRA version: 9.1Level: LLTClassification code 10057671Term: Female sexual dysfunction

• Registration Number: EUCTR2007-000013-10-NL
• Lead Sponsor: Pantarhei Bioscience B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-31
• Study Completion: 2009-06-16
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 82

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified