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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403401
• Other study ID #: 16803
• Status: Completed
• Phase: Phase 3
• Start date: May 15, 2015
• Est. completion date: July 7, 2016

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1471
• Est. completion date: July 7, 2016
• Est. primary completion date: July 7, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate (Pearl Index)	Pearl Index = Number of pregnancies per 100 woman-years of exposure	Up to 12 months
Secondary	Cumulative failure rate	Probability of getting pregnant	Up to 12 months

External Links

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