US Ovulation Inhibition Study in Obese Women

Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00873483

Enrollment

173

Registered

2009-04-01

Start date

2009-04-30

Completion date

2010-03-03

Last updated

2021-04-08

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

Conditions

Contraception

Keywords

Pregnancy prevention, female contraception, patch

Brief summary

Birth Control Patch Study

Interventions

DRUGEthinylestradiol/Gestodene (BAY86-5016)

0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Female subject requesting contraception * Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent * Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) * History of regular cyclic menstrual periods * Willingness to use non-hormonal methods of contraception during the entire study.

Exclusion criteria

* Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment) * Hypersensitivity to any ingredient of the study drug * Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape * Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis) * Any disease or condition that may worsen under hormonal treatment.

Design outcomes

Primary

Measure	Time frame
Determination of Hoogland Scores	Treatment Cycles 2 & 3

Secondary

Measure	Time frame
Laboratory values for E2, progesterone, FSH and LH	Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness	Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size	Pretreatment & regularly during Treatment Cycles 1, 2, 3

Countries

United States

Outcome results

None listed

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