Phase 2
N=150
Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Endometrial Atypical Hyperplasia · Endometrial Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01968317 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Cumulative CR Rates Within 16 Weeks — 23; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Megestrol acetate and metformin (Drug); Megestrol acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Xiaojun Chen
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative CR Rates Within 16 Weeks |
23; 12 | — |
| SECONDARY Cumulative CR Rates Within 32 Weeks |
52; 45 | — |
| SECONDARY Recurrence Rate |
7; 6 | — |
| SECONDARY Pregnancy Rate |
19; 15 | — |
Summary
The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Be between the ages of 18-45 years old
- Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D&C or hysteroscopy
- OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
- Have a desire for remaining reproductive function or uterus
- Need to be able to undergo correlative treatment and follow-up
Exclusion Criteria
- Have a history of serious liver or renal dysfunction
- Have a confirmed diagnosis of malignant tumor in genital system
- Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months
- Ask for removal of the uterus or other conservative treatment
- serum CA-125 > 35 Um/L
Data sourced from ClinicalTrials.gov (NCT01968317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.