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Clinical Trials/NCT00220324
NCT00220324
Completed
Phase 3

Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers

Bayer0 sites840 target enrollmentFebruary 2004
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ConditionsContraception
InterventionsMinisiston (SH D00342A)
DrugsMinisiston (SH D00342A)

Overview

Phase
Phase 3
Intervention
Minisiston (SH D00342A)
Conditions
Contraception
Sponsor
Bayer
Enrollment
840
Primary Endpoint
Unadjusted Pearl Index
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
November 2005
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy women requiring contraception

Exclusion Criteria

  • •Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Arms & Interventions

Arm 1

Intervention: Minisiston (SH D00342A)

Outcomes

Primary Outcomes

Unadjusted Pearl Index

Time Frame: After 13 cycles of intake

Secondary Outcomes

  • Bleeding pattern(After 13 cycles of intake)
  • Cycle control(After 13 cycles of intake)
  • Adjusted Pearl Index(After 13 cycles of intake)
  • Cumulative pregnancy rate(After 13 cycles of intake)

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