Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915915

Enrollment

108

Registered

2009-06-08

Start date

2009-06-30

Completion date

2010-04-30

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Ovulation Inhibition

Keywords

Female contraception, Ovulation inhibition

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

Interventions

DRUGEthinylestradiol/Gestodene (BAY86-5016)

Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI: 18 BMI 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/artial thromboembolic disease * Regular intake of medication other than OCs * Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3	4 months

Secondary

Measure	Time frame
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3	4 months
Course of gonadotropins (FSH, LH, P, E2)	4 months
Endometrial thickness and Follicle size	4 months
Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3	4 Months
Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3	4 Months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026