US Ovulation Inhibition Study in Obese Women

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00873483

Collaborator

(none)

173

Enrollment

Locations

Arm

10.1

Actual Duration (Months)

28.8

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Birth Control Patch Study

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Ethinylestradiol/Gestodene (BAY86-5016)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

173 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 30, 2009

Actual Primary Completion Date :

Mar 3, 2010

Actual Study Completion Date :

Mar 3, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Ethinylestradiol/Gestodene (BAY86-5016) 0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

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

Outcome Measures

Primary Outcome Measures

Determination of Hoogland Scores [Treatment Cycles 2 & 3]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85712
2	San Diego	California	United States	92108
3	Sandy Springs	Georgia	United States	30328
4	Philadelphia	Pennsylvania	United States	19114
5	Houston	Texas	United States	77054
6	Seattle	Washington	United States	98105