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

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	Not Applicable

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 (Clinical Trial)
• Estimated 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: February 2013
• Actual Primary Completion Date: June 16, 2019
• Estimated Study Completion Date: December 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 Name: 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 :

1. 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

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 51 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Rhode Island

Gynecologic practices affiliated with Women and Infants Hospital

Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

Women and Infants Hospital of Rhode Island

Investigators

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

More Information

• Responsible Party: Kristen Matteson , M.D., Associate Professor of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT02002260
• Other Study ID Numbers: R01HD074751 ( U.S. NIH Grant/Contract )
• First Posted: December 5, 2013
• Last Update Posted: August 2, 2021
• Last Verified: July 2021

Additional relevant MeSH terms:

Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Uterine Diseases; Levonorgestrel; Ethinyl Estradiol; Estradiol; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs