Endometrial HyperplasiaPhase 1/2NCT00123175
Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
A Phase 1/2 study testing Intrauterine Device in people with Endometrial Hyperplasia, run by Milton S. Hershey Medical Center.
Trial summary
The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia
- What is being tested?
- Intrauterine Device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 1/2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
- Normal pap smear within one year
Who cannot join
- Diabetes
- Family history of endometrial cancer
- Contraindications for the intrauterine device
About this study
Official title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.
Read the detailed description
Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.
- Conditions
- Endometrial Hyperplasia
- Being tested
- Intrauterine Device
- Keywords
- Endometrial Hyperplasia without atypia
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine DeviceDevice
Also called Medroxyprogesterone Acetate and Progestins
Mirena and Provera
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
Measured: 90 days
Secondary outcomes (3)
Side effects
Measured: 90 days
Bleeding profile
Measured: 90 days
Estradiol and progesterone levels
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Study has never received funding and has never been initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Women and Newborn Health
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard Legro, M.D., Principal investigator, Penn State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123175
- Sponsor's protocol ID
- 21012
- Status last verified
- Jan 2013
- First submitted
- 20 Jul 2005
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
- ClinicalTrials.gov ID
- NCT00123175
- Acronym / sponsor ID
- 21012
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial Hyperplasia without atypia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has never received funding and has never been initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Center for Research on Women and Newborn Health
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 22 Jul 2005 (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.
The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.
Detailed description
Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
- Normal pap smear within one year
Key exclusion criteria (3 listed)
- Diabetes
- Family history of endometrial cancer
- Contraindications for the intrauterine device
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 |
|---|---|---|
| Intrauterine DeviceAlso: Medroxyprogesterone Acetate and ProgestinsMirena and Provera | Device | – |
Primary outcome
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
Time frame: 90 days
3 secondary outcomes
Side effects
Time frame: 90 days
Bleeding profile
Time frame: 90 days
Estradiol and progesterone levels
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
Related trials for Endometrial Hyperplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
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.
Richard Legro, M.D. principal investigator
Penn State University College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intrauterine Device in people with Endometrial Hyperplasia, run by Milton S. Hershey Medical Center.
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 3 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: withdrawn, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera (time frame: 90 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 8 Jan 2013.