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OpenTrials
Completed

NCT Number: NCT00185484

Efficacy and Safety Oral Contraceptive Study

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

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 woman requesting contraception
  • Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion criteria

  • Any conditions might interfere study outcome

Treatment and study plan

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Drug

Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Primary outcomes

  1. Rate of unintended pregnancies (Pearl index)

    Time frame: 13 cycles of 28 days

Secondary outcomes

  1. Physical and gynecological examination

    Time frame: screening, cycle 6 and final examination

  2. Vital signs

    Time frame: each visit

  3. Body weight

    Time frame: each visit

  4. Cervical smear

    Time frame: each visit

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers

Important dates

Study start
2004
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 31, 2014

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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