Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-05-31

Brief Summary

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The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

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Detailed Description

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The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.

Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Levonogestrel Intrauterine system (LNG-IUS)

Contraception method

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Included participants with normal regular menses prior to LNG-IUS

insertion

* Included participants of any age, race, ethnicity, or parity
* Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
* Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days

Exclusion Criteria

* Heavy or prolonged menstrual bleeding (menorrhagia)
* Actively breastfeeding
* Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
* Hormonal injectable contraceptive use within 6 months of enrollment
* First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
* Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes