Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD 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

NCT01204190

Enrollment

173

Registered

2010-09-17

Start date

2010-09-30

Completion date

2011-08-31

Last updated

2014-11-04

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

Conditions

Contraception

Keywords

Administration, Cutaneous

Brief summary

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals. With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Interventions

DRUGGestodene/EE Patch (BAY86-5016)

0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy female volunteers * age 18 - 35 years (smoker not older than 30 years, inclusive) * ovulatory pre-treatment cycle

Exclusion criteria

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease) * Regular intake of medication other than Oral Contraception * Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Design outcomes

Primary

Measure	Time frame
Hoogland score to evaluate the inhibition of ovulation	After 2 months

Secondary

Measure	Time frame
Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone	After 2 months
Follicle size measured by transvaginal ultrasound examination	After 2 months
Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)	After 2 months

Countries

Germany, Netherlands

Outcome results

None listed

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