Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
This study has been withdrawn prior to enrollment.
(Study has never received funding and has never been initiated)
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123175
First received: July 20, 2005
Last updated: January 7, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | July 20, 2005 | ||||
| Last Updated Date | January 7, 2013 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Pathologic examination of the specimens obtained by endometrial biposy to determine the regression of endometrial hyperplasia without atypia compared to Provera. | ||||
| Change History | Complete list of historical versions of study NCT00123175 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Side effects, bleeding profile, estradiol and progesterone levels | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD) | ||||
| Official Title ICMJE | Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Endometrial Hyperplasia | ||||
| Intervention ICMJE | Device: Intrauterine Device
Mirena and Provera
Other Name: Medroxyprogesterone Acetate and Progestins |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00123175 | ||||
| Other Study ID Numbers ICMJE | 21012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Richard S. Legro, M.D., Milton S. Hershey Medical Center | ||||
| Study Sponsor ICMJE | Milton S. Hershey Medical Center | ||||
| Collaborators ICMJE | Center for Research on Women and Newborn Health | ||||
| Investigators ICMJE |
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| Information Provided By | Milton S. Hershey Medical Center | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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