Trial Outcomes & Findings for Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia (NCT NCT00503581)
NCT ID: NCT00503581
Last Updated: 2020-11-03
Results Overview
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 12 months after completion of treatment
Results posted on
2020-11-03
Participant Flow
Participant milestones
| Measure |
Regimen 1 (Megestrol Acetate, Surgery)
Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 2 (Megestrol Acetate, Surgery)
Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 3 (Surgery/Biopsy)
(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
Regimen 1 (Megestrol Acetate, Surgery)
Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 2 (Megestrol Acetate, Surgery)
Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 3 (Surgery/Biopsy)
(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
|---|---|---|---|
|
Overall Study
Study closed
|
3
|
4
|
2
|
Baseline Characteristics
Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
Baseline characteristics by cohort
| Measure |
Regimen 1 (Megestrol Acetate, Surgery)
n=3 Participants
Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 2 (Megestrol Acetate, Surgery)
n=4 Participants
Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 3 (Surgery/Biopsy)
n=2 Participants
(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
40-49 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
60-69 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
70-79 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after completion of treatmentPopulation: Treated and eligible participants. There were none.
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 12 monthsPopulation: Eligible and treated patients. This study was closed before subjects could complete evaluation.
Eligible and Treated patients. This study had 0 participants that completed study.
Outcome measures
Outcome data not reported
Adverse Events
Regimen 1 (Megestrol Acetate, Surgery)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen 2 (Megestrol Acetate, Surgery)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen 3 (Surgery/Biopsy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regimen 1 (Megestrol Acetate, Surgery)
n=3 participants at risk
Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 2 (Megestrol Acetate, Surgery)
n=4 participants at risk
Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Megestrol Acetate: given orally
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
Regimen 3 (Surgery/Biopsy)
n=2 participants at risk
(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.
Biopsy: Undergo biopsy
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: undergo hysterectomy
|
|---|---|---|---|
|
General disorders
Weight Gain
|
33.3%
1/3 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Up to 24 months
All Enrolled subjects.
|
25.0%
1/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
0.00%
0/3 • Up to 24 months
All Enrolled subjects.
|
25.0%
1/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
Vascular disorders
Hemorrhage, Gu - Uterus
|
0.00%
0/3 • Up to 24 months
All Enrolled subjects.
|
25.0%
1/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
33.3%
1/3 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
0.00%
0/3 • Up to 24 months
All Enrolled subjects.
|
25.0%
1/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Up to 24 months
All Enrolled subjects.
|
25.0%
1/4 • Up to 24 months
All Enrolled subjects.
|
0.00%
0/2 • Up to 24 months
All Enrolled subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60