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

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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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 ClinicalTrials.gov identifier (NCT number): NCT02002260


Locations
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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
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Principal Investigator: Kristen A Matteson, M.D., M.P.H. Women and Infants Hospital
More Information
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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    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Levonorgestrel
Ethinyl Estradiol
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Hormonal