Terminated/Withdrawn

Contraception, Ovulation Inhibition

Bayer Identifier:

91558

ClinicalTrials.gov Identifier:

NCT00729404

EudraCT Number:

2008-001198-13

EU CT Number:

Not Available

Inhibition of ovulation, patch, ethinylestradiol and gestodene

Trial purpose

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

Inclusion Criteria
- Signed informed consent,
- BMI: 18 - 30 kg/m²,
- Healthy female volunteers,
- Age 18-35 years (smoker not older than 30 years, inclusive),
- Ovulatory pre-treatment cycle, at least 3 month since delivery,
- Abortion or lactation before the first screening examination,
- Willingness to use non-hormonal methods of contraception during entire study
Exclusion Criteria
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
- Regular intake of medication other than OCs
- Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
- Anovulatory pre-treatment cycle

Trial summary

Enrollment Goal

Trial Dates

August 2008 - February 2009

Phase

Phase 2

Could I Receive a placebo

Products

Gestodene/EE Patch (BAY86-5016)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Terminated	Dinox GmbH Berlin	Berlin, 10115, Germany
Terminated	Bayer Schering Pharma AG - Clin. Pharm. Berlin	Berlin, 13342, Germany
Terminated	Landesamt für Gesundheit und Soziales	Berlin, 10707, Germany

Primary Outcome

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
Time Frame:
4 month
Safety Issue:
yes

Secondary Outcome

Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)
Time Frame:
4 month
Safety Issue:
yes
Course of gonadotropins (FSH, LH, P, E2)
Time Frame:
4 month
Safety Issue:
yes
Endometrial thickness
Time Frame:
4 month
Safety Issue:
yes
Follicle size
Time Frame:
4 month
Safety Issue:
yes
Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3
Time Frame:
4 month
Safety Issue:
yes

Trial design

Multicenter, open-label, randomized, uncontrolled study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg EE and either 1.05 or 2.1 mg GSD in healthy young female vol. over a period of 3 treatment cycles

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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