Heavy Menstrual BleedingPhase 4Mirena IUDNCT01391052
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
A Phase 4 study testing Norethindrone acetate pretreatment and No pretreatment in people with Heavy Menstrual Bleeding and Menorrhagia, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea
- What is being tested?
- Norethindrone acetate pretreatment and No pretreatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- You must be between 18-45 years old
- You have Heavy Periods
Who cannot join
- You are pregnant
- You are currently using hormonal contraception or hormonal therapy
- You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
- You had an infected abortion within the last three months
- You have abnormal or cancerous cells of the cervix or uterus
- You have an actine infection in your genital organs
Show all 11Show fewer
- Known or suspected breast cancer
- Active liver disease or tumors
- Allergy to levonorgestrel or norethindrone
- You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions
- you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scott and White Hospital and Clinic
Temple, Texas, 76508
Wendy M White, CCRP, 254-724-8301, wewhite@swmail.sw.org
Patricia J Sulak, MD
About this study
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.
Read the detailed description
This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea
- Being tested
- Norethindrone acetate pretreatment, No pretreatment
- Keywords
- Intrauterine system, reproductive age, menstrual bleeding
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone acetate pretreatmentDrug
Also called Aygestin
5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
No pretreatmentOther
LVN IUS is placed withour Norethindrone acetate pretreatment.
| Study group | Role | What they receive |
|---|---|---|
| Norethindrone acetate pretreatment | Active comparator | This arm will receive two cycles of norethindrone acetate before LVN IUS insertion. Receives: Drug: Norethindrone acetate pretreatment |
| No pretreatment | Other | LVN IUS is placed without norethindrone acetate pretreatment. Receives: Other: No pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of bleeding days
Number of days on study calendars with menstrual flow
Measured: up to 180 days
Secondary outcomes (1)
Menorrhagia Questionnaire
Patients will assess the impact of their menstrual bleeding on their lifestyle.
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Patricia J Sulak, MD, Principal investigator, Scott and White Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391052
- Sponsor's protocol ID
- 90378
- Acronym
- Mirena IUD
- Status last verified
- Jan 2011
- First submitted
- 7 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT01391052
- Acronym / sponsor ID
- Mirena IUD / 90378
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea
- Keywords
- Intrauterine system, reproductive age, menstrual bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 11 Jul 2011 (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.
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.
Detailed description
This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norethindrone acetate pretreatment | Active comparator | Drug: Norethindrone acetate pretreatmentThis arm will receive two cycles of norethindrone acetate before LVN IUS insertion. |
| No pretreatment | Other | Other: No pretreatmentLVN IUS is placed without norethindrone acetate pretreatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- You must be between 18-45 years old
- You have Heavy Periods
Key exclusion criteria (11 listed)
- You are pregnant
- You are currently using hormonal contraception or hormonal therapy
- You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
- You had an infected abortion within the last three months
- You have abnormal or cancerous cells of the cervix or uterus
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 |
|---|---|---|
| Norethindrone acetate pretreatmentAlso: Aygestin5 mg tablets, three times a day for 21 days for 2 menstrual cycles. | Drug | Norethindrone acetate pretreatment |
| No pretreatmentLVN IUS is placed withour Norethindrone acetate pretreatment. | Other | No pretreatment |
Primary outcome
Total number of bleeding days
Time frame: up to 180 days
Number of days on study calendars with menstrual flow
1 secondary outcome
Menorrhagia Questionnaire
Time frame: up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
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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.
Patricia J Sulak, MD principal investigator
Scott and White Hospital & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norethindrone acetate pretreatment and No pretreatment in people with Heavy Menstrual Bleeding and Menorrhagia, run by Scott and White Hospital & Clinic 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 2 inclusion and 11 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 11 Jul 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Wendy M White, CCRP (254-724-8301, wewhite@swmail.sw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of bleeding days (time frame: up to 180 days). 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 11 Jul 2011.