Condition category
Pregnancy and Childbirth
Date applied
19/11/2009
Date assigned
21/12/2009
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ellen Laan

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

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

http://www.pantarheibio.com/

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

Publication citations

Additional files

Editorial Notes