US Ovulation Inhibition Study in Obese Women

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873483
• Other study ID #: 13871
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2009
• Est. completion date: March 3, 2010

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Birth Control Patch Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: March 3, 2010
• Est. primary completion date: March 3, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ethinylestradiol/Gestodene (BAY86-5016)
0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Hoogland Scores		Treatment Cycles 2 & 3
Secondary	Laboratory values for E2, progesterone, FSH and LH		Pretreatment & regularly during Treatment Cycles 1, 2, 3
Secondary	Endometrial thickness		Pretreatment & regularly during Treatment Cycles 1, 2, 3
Secondary	Follicle size		Pretreatment & regularly during Treatment Cycles 1, 2, 3

External Links

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