Stopping Heavy Periods Project (SHiPP)

Women and Infants Hospital of Rhode Island

Status: Unknown

Conditions: Abnormal Uterine Bleeding, Ovulatory Dysfunction; Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction; Abnormal Uterine Bleeding

Treatments: Drug: Combined oral contraceptives; Device: Levonorgestrel intrauterine system

Study type: Interventional

Funder types: Other

Identifiers

NCT02002260

R01HD074751

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 59 estimated patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Levonorgestrel intrauterine system

Active Comparator group

Description:

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

Treatment:

Device: Levonorgestrel intrauterine system

Combined oral contraceptives

Active Comparator group

Description:

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)

Treatment:

Drug: Combined oral contraceptives