Abnormal Uterine BleedingSHiPPNCT02002260
Stopping Heavy Periods Project
A study testing Levonorgestrel intrauterine system and Combined oral contraceptives in people with Abnormal Uterine Bleeding and Abnormal Uterine Bleeding, Ovulatory Dysfunction, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Abnormal Uterine Bleeding, Ovulatory Dysfunction, Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
- What is being tested?
- Levonorgestrel intrauterine system and Combined oral contraceptives
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic practices affiliated with Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
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.
Read the 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.
- Conditions
- Abnormal Uterine Bleeding, Abnormal Uterine Bleeding, Ovulatory Dysfunction, Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
- Being tested
- Levonorgestrel intrauterine system, Combined oral contraceptives
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel intrauterine systemDevice
Also called Mirena
Combined oral contraceptivesDrug
Also called Any combined oral contraceptive of the provider's choice so long, as it contains 30-35 mg of ethinyl estradiol.
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel intrauterine system | Active comparator | levonorgestrel intrauterine system with 52 mg of levonorgestrel, levonorgestrel is released at a rate of approximately 20 μg/day. Inserted once, duration 5 years. Receives: Device: Levonorgestrel intrauterine system |
| Combined oral contraceptives | Active comparator | 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) Receives: Drug: Combined oral contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Bleeding Questionnaire
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
Measured: Completed 5 times over a one year time period
Secondary outcomes (1)
Treatment Failure
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).
Measured: Information collected at four time points during a one year period post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completion16 Jun 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Matteson , M.D., Women and Infants Hospital of Rhode Island
- Investigators
- Kristen A Matteson, M.D., M.P.H., Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002260
- Sponsor's protocol ID
- R01HD074751
- Acronym
- SHiPP
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2013
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
- ClinicalTrials.gov ID
- NCT02002260
- Acronym / sponsor ID
- SHiPP / R01HD074751
- Conditions
- Abnormal Uterine Bleeding, Abnormal Uterine Bleeding, Ovulatory Dysfunction, Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel intrauterine system | Active comparator | Device: Levonorgestrel intrauterine systemlevonorgestrel intrauterine system with 52 mg of levonorgestrel, levonorgestrel is released at a rate of approximately 20 μg/day. Inserted once, duration 5 years. |
| Combined oral contraceptives | Active comparator | Drug: Combined oral contraceptivesA 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) |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel intrauterine systemAlso: Mirena | Device | Levonorgestrel intrauterine system |
| Combined oral contraceptivesAlso: Any combined oral contraceptive of the provider's choice so long, as it contains 30-35 mg of ethinyl estradiol. | Drug | Combined oral contraceptives |
Primary outcome
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
1 secondary outcome
Treatment Failure
Time frame: Information collected at four time points during a one year period post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
Related trials for Abnormal Uterine Bleeding
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Uterine Hemorrhage
RecruitingObservational study
A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery
Uterine Hemorrhage, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen A Matteson, M.D., M.P.H. principal investigator
Women and Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel intrauterine system and Combined oral contraceptives in people with Abnormal Uterine Bleeding and Abnormal Uterine Bleeding, Ovulatory Dysfunction, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Bleeding Questionnaire (time frame: Completed 5 times over a one year time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.