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
DOI https://doi.org/10.1186/ISRCTN06414473
Protocol serial number PR3079
Sponsor Pantarhei Bioscience BV (Netherlands)
Funder Pantarhei Bioscience BV (Netherlands)
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

CHR Citadelle
Service gynécologie-obstétrique
1 boulevard du 12eme de ligne
Liege
B-4000
Belgium

Study information

Primary study designInterventional
Study designDouble-blind placebo-controlled randomised comparative single-centre trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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 acronymARC-AMUSA study
Study objectivesTo 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) studiedHormonal anticonception
InterventionEach 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 typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)Dehydroepiandrosterone, Yasmin® (drospirenone [DRSP], ethinyl estradiol [EE])
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.

Key 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

Completion date01/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target sample size at registration100
Key inclusion criteria1. 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 criteria1. 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
Date of first enrolment01/11/2007
Date of final enrolment01/07/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

CHR Citadelle
Liege
B-4000
Belgium

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2015 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

20/05/2016: Publication reference added.

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