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OpenTrials
Completed

NCT Number: NCT00220324

Pearl Index Study With Low Dose Combined Oral Contraceptive

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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hanover, Lower Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minisiston (SH D00342A)

Drug

Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval

Primary outcomes

  1. Unadjusted Pearl Index

    Time frame: After 13 cycles of intake

Secondary outcomes

  1. Adjusted Pearl Index

    Time frame: After 13 cycles of intake

  2. Cumulative pregnancy rate

    Time frame: After 13 cycles of intake

  3. Bleeding pattern

    Time frame: After 13 cycles of intake

  4. Cycle control

    Time frame: After 13 cycles of intake

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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