US Ovulation Inhibition Study in Obese Women

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00873483

13871

Details and patient eligibility

About

Birth Control Patch Study

Enrollment: 173 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestodene (BAY86-5016)