Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
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ClinicalTrials.gov Identifier: NCT00064025 |
Recruitment Status :
Completed
First Posted : July 9, 2003
Results First Posted : August 15, 2014
Last Update Posted : April 11, 2016
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Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Recurrent Uterine Corpus Carcinoma Stage I Uterine Corpus Cancer Stage II Uterine Corpus Cancer Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer |
Interventions |
Other: Laboratory Biomarker Analysis Drug: Medroxyprogesterone Procedure: Therapeutic Conventional Surgery |
Enrollment | 75 |
Participant Flow
Recruitment Details | The study was activated on 4/12/2004 and closed to accrual on 9/2/2008. |
Pre-assignment Details |
Arm/Group Title | Depo-Provera |
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Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy |
Period Title: Overall Study | |
Started | 75 |
Completed | 68 |
Not Completed | 7 |
Reason Not Completed | |
Ineligible | 4 |
Inevaluable | 3 |
Baseline Characteristics
Arm/Group Title | Depo-Provera | |
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Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy | |
Overall Number of Baseline Participants | 68 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 68 participants |
30-39 years | 1 | |
40-49 years | 3 | |
50-59 years | 28 | |
60-69 years | 30 | |
70-79 years | 3 | |
80-89 years | 3 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | |
Female |
68 100.0%
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Male |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jessalyn Reboy |
Organization: | Gynecologic Oncology Group Statistical and Data Center |
Phone: | 716-845-7738 |
EMail: | reboyj@norgoncology.org |
Responsible Party: | GOG Foundation ( Gynecologic Oncology Group ) |
ClinicalTrials.gov Identifier: | NCT00064025 |
Other Study ID Numbers: |
GOG-0211 NCI-2012-02539 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000306440 GOG-0211 ( Other Identifier: Gynecologic Oncology Group ) GOG-0211 ( Other Identifier: CTEP ) U10CA027469 ( U.S. NIH Grant/Contract ) |
First Submitted: | July 8, 2003 |
First Posted: | July 9, 2003 |
Results First Submitted: | January 31, 2014 |
Results First Posted: | August 15, 2014 |
Last Update Posted: | April 11, 2016 |