Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 403 for:    LEVONORGESTREL

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.
 
ClinicalTrials.gov Identifier: NCT02002260
Recruitment Status : Recruiting
First Posted : December 5, 2013
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 5, 2013
Last Update Posted Date October 17, 2018
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02002260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stopping Heavy Periods Project
Official Title  ICMJE Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abnormal Uterine Bleeding
  • Abnormal Uterine Bleeding, Ovulatory Dysfunction
  • Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2015)
59
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
212
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mindy Marshall, MS 401-274-1122 ext 48561 mamarshall@wihri.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02002260
Other Study ID Numbers  ICMJE R01HD074751( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island
Study Sponsor  ICMJE Women and Infants Hospital of Rhode Island
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP