Effects of concomitant treatment with an androgen on androgen metabolism, biochemical parameters, mood, fat, muscle and bone in women using an oral contraception
ISRCTN | ISRCTN06414473 |
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DOI | https://doi.org/10.1186/ISRCTN06414473 |
Secondary identifying numbers | PR3079 |
- Submission date
- 20/11/2009
- Registration date
- 21/12/2009
- Last edited
- 20/05/2016
- 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
Prof J.M. Foidart
Scientific
Scientific
CHR Citadelle
Service gynécologie-obstétrique
1 boulevard du 12eme de ligne
Liege
B-4000
Belgium
Study information
Study design | Double-blind placebo-controlled randomised comparative single-centre trial |
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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, single-centre trial to assess the effects on the androgen metabolism and its effect on biochemical parameters, mood, fat, muscle and bone of continuous supplementation with an androgen in women using a monophasic contraception |
Study acronym | ARC-AMUSA study |
Study objectives | To determine the effect of concomitant dehydroepiandrosterone (DHEA) compared to placebo in oral contraceptive (OC) users on androgen metabolism, biochemical parameters, mood, fat, muscle and bone. |
Ethics approval(s) | Local medical ethics committee (Comité d'Ethique of Centre Hospitalier Regional de la Citadelle, Liege, Belgium), 13/09/2007 |
Health condition(s) or problem(s) studied | Hormonal anticonception |
Intervention | Each cycle (28 days), daily intake of: 1. Yasmin® (3 mg drospirenone [DRSP]/30 μg ethinyl estradiol [EE]); only on day 1 - 21 2. 50 mg DHEA or placebo in two tablets; on day 1 - 28 Treatment periods: 1. Run-in period, 3 cycles: DRSP/EE 2. Treatment period, 6 cycles: DRSP/EE and DHEA or placebo 3. Treatment extension, 7 cycles: DRSP/EE and DHEA or placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Dehydroepiandrosterone, Yasmin® (drospirenone [DRSP], ethinyl estradiol [EE]) |
Primary outcome measure | 1. Androgen metabolism: albumin, Tot T, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), 4-androstenedione and 3 alpha androstanediol; calculated free thyroxine intake (FTI) and Free T 2. Oestradiol (E2) 3. Lipid metabolism: total cholesterol, high density liprprotein (HDL), low density lipoprotein (LDL) and triglycerides 4. Bone turn-over: serum osteocalcin and serum bone specific alkaline phosphatase (bone formation), serum CTX-I (bone resorption) and urine CTX-II (cartilage turnover) All parameters measured at screening/baseline and at the end of cycle 3, 6, 9, 12 and 16. |
Secondary outcome measures | 1. General effect, satisfaction, health related quality of life, sexual functioning, menstrual symptoms and mood will be assessed by PRO instruments; measured at baseline and at the end of cycle 3, 6, 9 and 16 2. Body weight (weekly measurement) 3. Muscle, fat and bone: fat distribution (waist to hip ratio), percentage of fat mass, lean mass and bone mass, muscle strength (six muscles); measured at baseline and at the end of cycle 3, 9 and 16 4. Other endocrine parameters: fasting glucose, insulin, HbA1c, thyroid stimulating hormome (TSH), triiodothyronine (T3), cortisol, adrenocorticotropic hormone (ACTH); measured at screening/baseline and at the end of cycle 3, 9 and 16 5. Acceptability: discontinuation rates and reasons for discontinuations 6. Safety (vital signs, physical, gynaecological and breast examinations, safety lab, skin characteristics, bleeding data, [serious] adverse events, pregnancy), measured throughout the study |
Overall study start date | 01/11/2007 |
Completion date | 01/07/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 100 |
Key inclusion criteria | 1. Healthy females between 18 and 35 years of age who are in need for OC 2. No use of hormonal contraceptive treatment for at least 3 months prior to randomisation 3. Willing to use an OC for 9 subsequent cycles 4. Willing to have a documented spontaneous cycle for baseline observation without the use of any hormonal contraceptive treatment 5. Sexually active women 6. Regular menstrual cycle (24 - 35 days) prior to screening 7. Body mass index (BMI) between (greater than or equal to) 18 and (less than or equal to) 35 kg/m^2 8. Good physical and mental health 9. Sign a written informed consent agreement |
Key exclusion criteria | 1. Contraindications for OC 2. Failure to ovulate during the documented spontaneous cycle for baseline observation 3. Use of hormonal contraceptive method during documented spontaneous cycle 4. Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation 5. Use of any long term hormonal contraceptive method within 3 months after the limit of efficacy prior to screening 6. Androgen therapy during the 6 months prior to screening 7. Polycystic ovarian syndrome 8. Hyperandrogenism documented by free serum T value (greater than or equal to 9 pg/mL), severe acne and/or hirsutism at screening 9. No spontaneous menstruation has occurred following a delivery or abortion 10. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation 11. Intention to become pregnant during the study 12. An abnormal cervical smear at screening 13. Any clinically significant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening 14. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening 15. History of/or current (treated) skin disorder (e.g. acne) which might be influenced by the study treatment 16. Use of any relevant treatment for a skin disorder at the time of screening 17. Use of one or more of the following medications: psychoactive drugs, anti-hypertensive drugs 18. Present use or use within 30 days prior to the start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St Johns Wort) 19. Administration of any other investigational drug within 3 months prior to screening |
Date of first enrolment | 01/11/2007 |
Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
CHR Citadelle
Liege
B-4000
Belgium
B-4000
Belgium
Sponsor information
Pantarhei Bioscience BV (Netherlands)
Industry
Industry
PO Box 464
Zeist
3700 AL
Netherlands
Website | http://www.pantarheibio.com |
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https://ror.org/03hagz796 |
Funders
Funder type
Industry
Pantarhei Bioscience BV (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/02/2015 | Yes | No |
Editorial Notes
20/05/2016: Publication reference added.