Skip to main content
OpenTrials
Completed

NCT Number: NCT00920985

US Cycle Control and Blood Pressure Study

Birth Control Patch Study

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subject requesting contraception
  • Age: 18 - 45 years (inclusive); smokers must not be older than 35 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

Exclusion criteria

  • Pregnancy or lactation
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication

Treatment and study plan

Gestodene/EE (FC Patch Low, BAY86-5016)

Drug

21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2

Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A

Drug

21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1

Primary outcomes

  1. Cycle control parameters and bleeding pattern indices

    Time frame: Treatment cycles 2-7

Secondary outcomes

  1. Number of pregnancies while on treatment up to 14 days after removal of the last patch

    Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days

  2. Evaluation of blood pressure changes during the dosing-free interval

    Time frame: 7 treatment cycles each consisting of 28 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2009
Registry last updated
Oct 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.