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

ISRCTN	ISRCTN03247616
DOI	https://doi.org/10.1186/ISRCTN03247616
Protocol serial number	PR3042
Sponsor	Pantarhei Bioscience BV (Netherlands)
Funder	Pantarhei Bioscience BV (Netherlands)

Submission date: 19/11/2009
Registration date: 21/12/2009
Last edited: 14/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ellen Laan
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Study information

Primary study design	Interventional
Study design	Double-blind placebo controlled randomised comparative 2-way crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A double-blind, placebo controlled, randomised, comparative 2-way crossover study to determine the effect of concomitant treatment with an androgen on sexual arousability and the vascular component of the sexual arousal response during self-induced erotic fantasy and visual stimulation in women using oral contraception
Study acronym	ARC-AMC study
Study objectives	To determine the effect of concomitant dehydroepiandrosterone (DHEA) compared to placebo in the two treatment groups of oral contraception (OC) users on different aspects of sexual functioning.
Ethics approval(s)	Medische Etische Commissie (AMC) approved on the 18th March 2007 and 13th September 2007
Health condition(s) or problem(s) studied	Hormonal anticonception
Intervention	Each cycle (28 days), daily intake of: 1. Microgynon® (150 µg levonorgestrel [LNG]/30 µg ethinyl estradiol [EE]) or Yasmin® (3 mg drospirenone [DRSP]/30 µg EE); on day 1 - 21 2. 50 mg DHEA or placebo in two tablets; on day 1 - 28 Pretest period: 1 cycle (no OC) Treatment period 1: 5 cycles Treatment period 2: 5 cycles Total treatment duration: 10 cycles (each cycle: 28 days)
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Dehydroepiandrosterone, Microgynon® (levonorgestrel [LNG], ethinyl estradiol [EE]), Yasmin® (drospirenone [DRSP], EE)
Primary outcome measure(s)	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) 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 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
Key secondary outcome measure(s)	1. Androgen parameters, measured at screening, pretest visit, study visit at end of each treatment period 2. Daily hassles, completed during the last two treatment cycles of each treatment period 3. Health diary, completed during the last two treatment cycles of each treatment period 4. Haemostasis metabolism, measured at screening, pretest visit, study visit at end of each treatment period 5. Bleeding data, measured with diary keeping during both treatment periods 6. Safety assessment, measured throughout the study
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	84
Total final enrolment	81
Key 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
Key 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
Date of first enrolment	01/05/2007
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018	14/10/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.