Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR3042
Study information
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
Acronym
ARC-AMC study
Study hypothesis
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
Medische Etische Commissie (AMC) approved on the 18th March 2007 and 13th September 2007
Study design
Double-blind placebo controlled randomised comparative 2-way crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Dehydroepiandrosterone, Microgynon® (levonorgestrel [LNG], ethinyl estradiol [EE]), Yasmin® (drospirenone [DRSP], EE)
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/05/2007
Overall trial end date
01/07/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
84
Participant 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
Recruitment start date
01/05/2007
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Pantarhei Bioscience BV (Netherlands)
Sponsor details
PO Box 464
Zeist
3700 AL
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pantarhei Bioscience BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary