Official Title: “A Multicenter, Open-Label, Three-Arm, Active-Controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D in Two Flexible Extended Regimens and a Conventional Regimen of Yaz in 1756 Healthy Females for 1 Year”

The purpose of this study is to determine whether the study drug is safe and effective

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: December 2009

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Intervention(s) in this Clinical Trial

• Drug: SH T00186D
  • 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
• Drug: SH T00186D
  • 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
• Drug: SH T00189D, SH T470PD
  • 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone + placebo tablet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 2
  • n/a
• Active Comparator: Arm 3
  • n/a
• Active Comparator: Arm 1
  • n/a

Primary Measures

• The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment.
  • Time Frame: Approximately 1 year
    Safety Issue?: Yes

Secondary Measures

• The secondary efficacy parameters include bleeding parameters and menstrual related symptoms.
  • Time Frame: Approximately 1 year
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy women between 18 and 45 requesting oral contraception.
• Smokers may not exceed 35 years of age.

Exclusion Criteria:

• The use of steroidal oral contraceptives , or any drug that could alter Oral contraception metabolism will be prohibited during the study.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trial Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567164

Study ID Number: 91698

ClinicalTrials.gov Identifier: NCT00567164

Health Authority: United States: Food and Drug Administration

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