A double-blind, placebo-controlled, randomized, N=1 study to determine the effect of concomitant treatment with dehydroepiandrosterone (50 mg) on sexual functioning in 6 women who experience a decrease in sexual functioning due to their oral contraception-use. - ARC-SOLO

Pantarhei Bioscience BV0 个研究点目标入组 6 人开始时间: 2008年1月7日最近更新: 2022年4月4日

试验速览

暂无简介。

•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 (<) 14.
•8.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

•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

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