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Stopping Heavy Periods Project (SHiPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Information provided by (Responsible Party):
Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT02002260
First received: November 27, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

This study is a randomized clinical trial comparing the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for treatment of heavy menstrual bleeding. 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 and will be associated with fewer treatment failures and greater cost-effectiveness at one year. To test these hypotheses, we plan to enroll 212 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.


Condition Intervention
Abnormal Uterine Bleeding
Abnormal Uterine Bleeding, Ovulatory Dysfunction
Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Device: Levonorgestrel intrauterine system
Drug: Combined oral contraceptives

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Menstrual Bleeding Questionnaire [ Time Frame: Completed 5 times over a one year time period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Information collected at four time points during a one year period post randomization ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 212
Study Start Date: February 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 51 Years
Genders 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 on COCs or have an IUD in place
  • History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002260

Contacts
Contact: Tracey Ferreira 401-274-1122 ext 48553 tfferreira@wihri.org

Locations
United States, Rhode Island
Gynecologic practices affiliated with Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Tracey Ferreira       TFFerreira@wihri.org   
Principal Investigator: Kristen A. Matteson, MD, MPH         
Sub-Investigator: Melissa A. Clark, PhD         
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

No publications provided

Responsible Party: Kristen Matteson , M.D., Assistant Professor of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02002260     History of Changes
Other Study ID Numbers: R01HD074751
Study First Received: November 27, 2013
Last Updated: December 4, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Uterine Hemorrhage
Hemorrhage
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Levonorgestrel
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014