COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Stopping Heavy Periods Project (SHiPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02002260
Recruitment Status : Recruiting
First Posted : December 5, 2013
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):
Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island

Brief Summary:
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 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.

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

Layout table for study information
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
Study Start Date : February 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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.

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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02002260

Layout table for location contacts
Contact: Mindy Marshall, MS 401-274-1122 ext 48561

Layout table for location information
United States, Rhode Island
Gynecologic practices affiliated with Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Tracey Ferreira   
Principal Investigator: Kristen A. Matteson, MD, MPH         
Sub-Investigator: Melissa A. Clark, PhD         
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Layout table for investigator information
Principal Investigator: Kristen A Matteson, M.D., M.P.H. Women and Infants Hospital

Layout table for additonal information
Responsible Party: Kristen Matteson , M.D., Associate Professor of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island Identifier: NCT02002260    
Other Study ID Numbers: R01HD074751 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic