SHiPP: Stopping Heavy Periods Project

Sponsor

Women and Infants Hospital of Rhode Island (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02002260

Collaborator

(none)

Enrollment

Location

Arms

106.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding Abnormal Uterine Bleeding, Ovulatory Dysfunction Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction	Device: Levonorgestrel intrauterine system Drug: Combined oral contraceptives	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 16, 2019

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Levonorgestrel intrauterine system Other Names: Mirena
Active Comparator: 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)	Drug: Combined oral contraceptives Other Names: Any combined oral contraceptive of the provider's choice so long as it contains 30-35 mg of ethinyl estradiol.

Arm

Intervention/Treatment

Active Comparator: 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.

Device: Levonorgestrel intrauterine system

Other Names:

Mirena

Active Comparator: 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)

Drug: Combined oral contraceptives

Other Names:

Any combined oral contraceptive of the provider's choice so long

as it contains 30-35 mg of ethinyl estradiol.

Outcome Measures

Primary Outcome Measures

Menstrual Bleeding Questionnaire [Completed 5 times over a one year time period]
We will measure bleeding-specific quality of life using the Menstrual Bleeding Questionnaire (MBQ), a validated tool to assess bleeding-related quality of life, which is the most important outcome for patients and for clinicians treating this symptom. We will measure MBQ score at randomization, and at 6 weeks, 3 month, 6 months, and 12 months post-randomization for both groups

Secondary Outcome Measures

Treatment Failure [Information collected at four time points during a one year period post randomization]
The goal of treating heavy menstrual bleeding is to utilize a treatment option that improves patient quality of life and avoids surgical intervention. We will look at treatment failure two different ways. We will determine the overall proportion of participants who discontinued their assigned treatment (opted for no treatment or chose a different treatment option, including surgery) and subset that opted for surgical intervention (endometrial ablation or hysterectomy) during the study period. This information will be recorded by the primary gynecologic provider (physical examination and physician form), by participants (interval health history form), and by the research team (medical record review).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 51 Years

Sexes Eligible for Study:

Female

Accepts 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