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OpenTrials
Completed

NCT Number: NCT02403401

Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Funabashi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy female subject requesting contraception and willing to use the IVR
  • Normal or clinically insignificant 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
  • Subject is willing and able to attend the scheduled study visits and comply with study procedures

Exclusion criteria

  • Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator
  • Undiagnosed abnormal genital bleeding
  • Wish for pregnancy during the study
  • Major surgery scheduled during the study period

Treatment and study plan

Levonorgestrel (BAY98-7196)

Drug

Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)

Primary outcomes

  1. Pregnancy rate (Pearl Index)

    Time frame: Up to 12 months

    Pearl Index = Number of pregnancies per 100 woman-years of exposure

Secondary outcomes

  1. Cumulative failure rate

    Time frame: Up to 12 months

    Probability of getting pregnant

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multi-center, Open-label, Single-arm Study to Assess the Safety and Contraceptive Efficacy of a Levonorgestrel-containing Intravaginal Ring During a Treatment Period of One Year in Healthy Women 18 to 35 Years of Age

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2015
Registry last updated
Apr 8, 2021

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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