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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | Effects of concomitant treatment with an androgen on androgen metabolism, biochemical parameters, mood, fat, muscle and bone in women using an oral contraception |
| 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 |
| Acronym | ARC-AMUSA study |
| Serial number at source | PR3079 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Local medical ethics committee (Comité d'Ethique of Centre Hospitalier Regional de la Citadelle, Liege, Belgium) approved on the 13th September 2007. |
| Study design | Double-blind placebo controlled randomised comparative single-centre trial |
| Countries of recruitment | Belgium |
| Disease/condition/study domain | Hormonal anticonception |
| Participants - 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 |
| Participants - 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 John’s Wort) 19. Administration of any other investigational drug within 3 months prior to screening |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/07/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Pantarhei Bioscience BV (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Prof J.M. Foidart |
| Address |
CHR Citadelle
Service gynécologie-obstétrique 1 boulevard du 12eme de ligne |
| City/town | Liege |
| Zip/Postcode | B-4000 |
| Country | Belgium |
| Sponsor | Pantarhei Bioscience BV (Netherlands) |
| Address | PO Box 464 |
| City/town | Zeist |
| Zip/Postcode | 3700 AL |
| Country | Netherlands |
| Sponsor website: | http://www.pantarheibio.com |
| Date applied | 20/11/2009 |
| Last edited | 21/12/2009 |
| Date ISRCTN assigned | 21/12/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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