Stopping Heavy Periods Project (SHiPP)

• ClinicalTrials.gov Identifier: NCT02002260
• Recruitment Status: Active, not recruiting
• First Posted: December 5, 2013
• Last Update Posted: August 2, 2021
• Sponsor: Women and Infants Hospital of Rhode Island
• Information provided by (Responsible Party): Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island

Tracking Information

• First Submitted Date: November 27, 2013
• First Posted Date: December 5, 2013
• Last Update Posted Date: August 2, 2021
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: June 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2013)

Menstrual Bleeding Questionnaire [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2013)

Treatment Failure [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stopping Heavy Periods Project
• Official Title: Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Device: Levonorgestrel intrauterine system
  Other Name: Mirena
• 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.

Study Arms

• 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.
  Intervention: Device: Levonorgestrel intrauterine system
• 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)
  Intervention: Drug: Combined oral contraceptives

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 24, 2015): 59
• Original Estimated Enrollment (submitted: December 4, 2013): 212
• Estimated Study Completion Date: December 31, 2021
• Actual Primary Completion Date: June 16, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 51 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02002260
• Other Study ID Numbers: R01HD074751( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island
• Study Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kristen A Matteson, M.D., M.P.H.; Women and Infants Hospital

• PRS Account: Women and Infants Hospital of Rhode Island
• Verification Date: July 2021