Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR3079
Study information
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
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.
Ethics approval
Local medical ethics committee (Comité d'Ethique of Centre Hospitalier Regional de la Citadelle, Liege, Belgium), 13/09/2007
Study design
Double-blind placebo-controlled randomised comparative single-centre trial
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. 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
Phase
Phase II
Drug names
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 trial start date
01/11/2007
Overall trial end date
01/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant 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
Recruitment start date
01/11/2007
Recruitment end date
01/07/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
CHR Citadelle
Liege
B-4000
Belgium
Sponsor information
Organisation
Pantarhei Bioscience BV (Netherlands)
Sponsor details
PO Box 464
Zeist
3700 AL
Netherlands
Sponsor type
Industry
Website
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25604900