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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02403401
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel (BAY98-7196) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1471 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : May 15, 2015
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : July 7, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levonorgestrel (BAY98-7196)
Vaginal ring containing 170 mg levonorgestrel
Drug: Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)




Primary Outcome Measures :
  1. Pregnancy rate (Pearl Index) [ Time Frame: Up to 12 months ]
    Pearl Index = Number of pregnancies per 100 woman-years of exposure


Secondary Outcome Measures :
  1. Cumulative failure rate [ Time Frame: Up to 12 months ]
    Probability of getting pregnant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403401


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02403401     History of Changes
Other Study ID Numbers: 16803
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Pregnancy prevention

Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral