Stopping Heavy Periods Project

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2021-12-31

Brief Summary

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This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.

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Detailed Description

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This study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. We hypothesize that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related quality of life at 6 months and one year. To test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.

Conditions

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Abnormal Uterine Bleeding Abnormal Uterine Bleeding, Ovulatory Dysfunction Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levonorgestrel intrauterine system

levonorgestrel intrauterine system with 52 mg of levonorgestrel, levonorgestrel is released at a rate of approximately 20 μg/day. Inserted once, duration 5 years.

Group Type ACTIVE_COMPARATOR

Levonorgestrel intrauterine system

Intervention Type DEVICE

Combined oral contraceptives

A combined ethinyl estradiol (ee) and progestin oral contraceptive pill chosen by the participants' primary gynecologic care provider. Monophasic with 30 or 35 mcg ee administered according to pill pack instructions (21 days active pills, 7 placebo pills)

Group Type ACTIVE_COMPARATOR

Combined oral contraceptives

Intervention Type DRUG

Interventions

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Levonorgestrel intrauterine system

Intervention Type DEVICE

Combined oral contraceptives

Intervention Type DRUG

Other Intervention Names

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Mirena Any combined oral contraceptive of the provider's choice so long as it contains 30-35 mg of ethinyl estradiol.

Eligibility Criteria

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Inclusion Criteria

* Self-reported heavy menstrual bleeding
* Age 18-51 years
* Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E)

Exclusion Criteria

* Plan pregnancy in the next year
* Menopausal
* Currently has a copper IUD in place
* History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS

Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No