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

Bayer0 sites17 target enrollmentAugust 2008

ConditionsContraception Ovulation Inhibition

InterventionsEthinylestradiol/Gestodene (BAY86-5016)

DrugsEthinylestradiol/Gestodene (BAY86-5016)

Overview

Phase: Phase 2
Intervention: Ethinylestradiol/Gestodene (BAY86-5016)
Conditions: Contraception
Sponsor: Bayer
Enrollment: 17
Primary Endpoint: The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Detailed Description

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

February 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm 1

Intervention: Ethinylestradiol/Gestodene (BAY86-5016)

Arm 2

Intervention: Ethinylestradiol/Gestodene (BAY86-5016)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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