Condition category
Pregnancy and Childbirth
Date applied
20/11/2009
Date assigned
21/12/2009
Last edited
20/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J.M. Foidart

ORCID ID

Contact details

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

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 measures

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

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 John’s 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

http://www.pantarheibio.com

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25604900

Publication citations

Additional files

Editorial Notes

20/05/2016: Publication reference added.