Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00729404

Enrollment

Registered

2008-08-07

Start date

2008-08-31

Completion date

2009-02-28

Last updated

2014-12-02

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

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.

Interventions

DRUGEthinylestradiol/Gestodene (BAY86-5016)

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

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

* 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

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 month

Secondary

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

Countries

Germany

Outcome results

None listed

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