US Ovulation Inhibition Study in Obese Women

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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)

173 participants in 1 patient group

Arm 1
Experimental group
Treatment:
Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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