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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 - Inhibition of ovulation and pharmacokinetics of transdermal EE and 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 - Inhibition of ovulation and pharmacokinetics of transdermal EE and GSD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009177-10-DE
Enrollment
Unknown
Registered
2009-03-23
Start date
2009-04-30
Completion date
Unknown
Last updated
2013-03-04

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

Conditions

The trial will be performed in healthy female volunteers. The intended indication is femal contraception.

Interventions

Product Name: FC Patch Low Product Code: 80876395 Pharmaceutical Form: Transdermal patch INN or Proposed INN: Ethinylestradiol CAS Number: 57-63-6 Current Sponsor code: ZK 4944 Concentration unit: mg

Sponsors

Bayer HealthCare AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed informed consent prior to study participation and confirmation of the volunteer’s health insurance coverage Healthy female volunteer Age: 18 – 35 years (inclusive) at the first screening examination (smokers not older than 30 years, inclusive) Body mass index (BMI): 18 = BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindications for use of a combined (estrogen/progesteron) contraception (e.g. history of venous/arterial thromembolic disease) regular intake of medication other than OCs Clinical relevant findings (heart rate, blood pressure, physical, gynecological examination, laboratory examination) Anovulatory pre-treatment cycle Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria) Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of this study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 administration of two different patches containing ethinylestradiol (EE) / gestodene (GSD) for 3 treatment cycles;Secondary Objective: The following evaluations represent the secondary objectives: Ovarian activity during treatment cycles 2 and 3 (Hoogland score) Course of gonadotropins (FSH, LH), progesterone and E2 Endometrial thickness Follicle size Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3 Pharamcokinetics of EE, GSD and SHBG in treatment cycles 2 and 3 Proof of ovulation in the follow-up cycle;Primary end point(s): The primary variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable "ovulation" (i.g. Hoogland score 6) with the levels "yes" and "no"—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026