Clinical Trials Register

Summary
EudraCT Number:	2007-003788-28
Sponsor's Protocol Code Number:	PR3079
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-09-11
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2007-003788-28

A.3

Full title of the trial

A double-blind, placebo controlled, randomized, comparative, mono-centre trial to assess the effects on the androgen metabolism and its effects on biochemical parameters, mood, fat, muscle and bone of continuous supplementation with dehydroepiandrosterone in women using a monophasic contraception containing drospirenone and ethinylestradiol

A.3.2

Name or abbreviated title of the trial where available

AMUSA

A.4.1

Sponsor's protocol code number

PR3079

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pantarhei Bioscience B.V.
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Yasmin
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	G03AA
D.3.4	Pharmaceutical form	Gastro-resistant capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DROSPIRENONE
D.3.9.1	CAS number	67392874
D.3.9.3	Other descriptive name	DRSP
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETHINYLESTRADIOL
D.3.9.1	CAS number	57-63-6
D.3.9.3	Other descriptive name	EE
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	dehydroepiandrosterone (DHEA)
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRASTERONE
D.3.9.1	CAS number	53430
D.3.9.3	Other descriptive name	DHEA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Biochemical disturbances (androgens, lipids, bone markers, endocrine) and mood disturbances caused by the use of Oral Contraception (OC).

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the biochemical effects with special emphasize on androgen metabolism, estradiol, lipid metabolism and bone turn-over of continuous DHEA supplementation in a group of 50 women aged 18-35 years using DRSP-EE contraception compared to a control group of 50 women aged 18-35 years receiving DRSP-EE contraception alone
TREATMENT EXTENSION:
Primary objective:
To evaluate the long-term treatment effects of continuous DHEA supplementation on bone metabolism

E.2.2

Secondary objectives of the trial

1) To evaluate the effects of DHEA supplementation on satisfaction and health related quality of life, sexual functioning, menstrual symptoms, mood, skin characteristics, body weight, muscle, fat and bone and other endocrine parameters
2) To evaluate general safety and acceptability of continuous DHEA supplementation
TREATMENT EXTENSION:
1) To collect long-term efficacy data
2) To collect long-term safety and acceptability data

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Women aged 18-35 years (inclusive) who are in need for contraception and willing to use an OC for 9 subsequent cycles and who have not been using hormonal contraceptive treatment for at least 3 months prior to randomization;
2. Willing to have a documented spontaneous cycle for baseline observation without the use of any hormonal contraceptive treatment and willing to use a non-hormonal contraception instead prior to start study medication;
3. Sexually active women;
4. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vitals signs;
5. Regular menstrual cycle (24-35 days) prior to screening;
6. At least 18 but not older than 35 years of age at the time of screening;
7. Body mass index between (≥) 18 and (≤) 35 kg/m2;
8. Willing to give informed consent in writing.
Continued eligibility inclusion criteria for enrolment in the treatment extension:
1. Women completing the 9 treatment cycles of the main study who are still fulfilling the study criteria and who are willing to use an OC for another 7 subsequent cycles;
2. Good physical and mental health as judged by the investigator determined by physical examination, clinical laboratory and vital signs;
3. Willing to give informed consent in writing.

E.4

Principal exclusion criteria

1. Failure to ovulate during the documented spontaneous cycle for baseline observation defined as absence of ovulation documented by a plasma progesterone level of ≤ 1.5 ng/ml measured during the expected luteal phase on a cycle day calculated based on (i) the duration of the spontanuous menstrual cycle in the past, (ii) the duration of the first and the second cycle in case a subject is undergoing a three-month washout period for a contraceptive method. (note: in case of anovulatory cycle, a second baseline observational cycle may be monitored, but in case of two consecutive ovulation failures, the subject will be excluded);
2. Use of any hormonal contraceptive method during the documented spontaneous cycle prior to start of study medication;
3. Previous use of any hormonal contraceptive method during the last 3 months prior to screeningrandomization;
4. Use of any long term hormonal method (e.g. Depo-provera®) of contraception within 3 months after the limit of efficacy determined according to the manufacturer and no spontaneous return of menstruation prior to screening;
5. Androgen therapy during the 6 months prior to screening;
6. Polycystic Ovarian Syndrome documented by either previous clinical abnormal cyclicity and/or FSH/LH ratio or echographic documentation of multiple cystic ovarian syndrome;
7. Hyperandrogenism documented by free serum testosterone value ( 9 pg/mL), severe acne and/or hirsutism;
8. No spontaneous menstruation has occurred following a delivery or abortion;
9. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation;
10. Intention to become pregnant during the study;
11. An abnormal cervical smear
12. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening;
13. History of/or current (treated) skin disorder;
14. Any clinically significant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening as judged by the investigator;
15. Contraindications for contraceptive steroids:
16 ... 19
Continued eligibility exclusion criteria for enrolment in the treatment extension:
1. Use of any hormonal contraceptive method (except the study medication) during and/or directly after the blinded treatment period of the main study;
2. Androgen therapy during and directly after the blinded treatment period of the main study;
3. Any medical event occurring or condition arising during the study period of the main study that, in the opinion of the investigator, could interfere with optimal participation in the study or jeopardize the subjects health if left untreated;
4. Any clinically significant abnormality following review of laboratory results at Visit 6 as judged by the Investigator;
5. Subjects with a positive result for pregnancy test at Visit 6;
6. Non-compliance with the study medication during the main study to such extent that the evaluation of study data is compromised.

E.5 End points

E.5.1

Primary end point(s)

Androgen metabolism
Estradiol
Lipid metabolism
Bone turn-over

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Information not present in EudraCT

E.6.2

Prophylaxis

Information not present in EudraCT

E.6.3

Therapy

Yes

E.6.4

Safety

Information not present in EudraCT

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Information not present in EudraCT

E.6.7

Pharmacodynamic

Information not present in EudraCT

E.6.8

Bioequivalence

Information not present in EudraCT

E.6.9

Dose response

Information not present in EudraCT

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

Information not present in EudraCT

E.6.12

Pharmacoeconomic

Information not present in EudraCT

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the trial will be as soon as the 100th subject has had her final trial visit (Visit 7 - Follow up visit).
For subjects participating in the treatment extension the end of trial will be when the last subject has completed Visit 9 (Follow up visit)
Trial period (treatment extension): October 2008 – May 2010

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	Yes
F.3.2	Patients	No
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-09-11.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	100

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-11-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-09-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-04

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