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 |
| Secondary identifying numbers | PR3042 |
- 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
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Double-blind placebo controlled randomised comparative 2-way crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Dehydroepiandrosterone, Microgynon® (levonorgestrel [LNG], ethinyl estradiol [EE]), Yasmin® (drospirenone [DRSP], EE) |
| Primary outcome measure | 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 study start date | 01/05/2007 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Pantarhei Bioscience BV (Netherlands)
Industry
Industry
PO Box 464
Zeist
3700 AL
Netherlands
| Website | http://www.pantarheibio.com/ |
|---|---|
"ROR" |
https://ror.org/03hagz796 |
Funders
Funder type
Industry
Pantarhei Bioscience BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
