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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02403401

Enrollment

1471

Registered

2015-03-31

Start date

2015-05-15

Completion date

2016-07-07

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Pregnancy prevention

Brief summary

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

Interventions

DRUGLevonorgestrel (BAY98-7196)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pregnancy rate (Pearl Index)	Up to 12 months	Pearl Index = Number of pregnancies per 100 woman-years of exposure

Secondary

Measure	Time frame	Description
Cumulative failure rate	Up to 12 months	Probability of getting pregnant

Countries

Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026