Trial · NCT02035787
Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
NCT02035787, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2024-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients. Trials, record NCT02035787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02035787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
- NCT number
- NCT02035787
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Complex Atypical Hyperplasia, Endometrial Cancer
- Interventions
- Metformin
- First posted
- 2014-01-14
- Last updated
- 2024-12-18
- Results first posted
- 2024-12-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate - 6 Months | Up to 6 months | Complete Response is subjects with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma percentage of individuals achieved complete disease regression as defined by no evidence of microscopic viable hyperplasia or carcinoma on endometrial biopsy. |
| Secondary | Complete Response Rate by Group | Up to 6 months | Complete Response is the percentage of individuals achieving complete disease regression as defined by no evidence of microscopic viable hyperplasia or carcinoma on endometrial biopsy in complex atypical hyperplasia and Grade 1 endometrial adenocarcinoma groups. The group are based on the initial treatment assignment and not on the treatment eventually received. |
| Secondary | Percent Complete Response Rate-12 Months | Up to 12 months | Complete Response is the percentage of participants achieving complete disease regression as defined by no evidence of microscopic viable hyperplasia or carcinoma on endometrial biopsy. |
| Secondary | Adherence of Treatment | 12 months | Patients adhered to at least 80% of the scheduled doses throughout the prescribed treatment period. Subjects who achieved a biopsy-proven complete response stopped the treatment early but were still considered adherent to the treatment. |
| Secondary | Treatment Attributed Adverse Events | Up to 12 months | All treatment-attributed adverse events (definite, possible, and probable) with grade information are reported based on The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. CTCAE is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate - 6 Months | Up to 6 months | Subjects who are with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma, started the study treatment, and an endometrial biopsy was performed to assess the treatment response, regardless of completion of the study medication. | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate by Group | Up to 6 months | Subjects who are with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma, started the study treatment, and an endometrial biopsy was performed to assess the treatment response, regardless of completion of the study medication. | percentage of participants | NUMBER |
| SECONDARY | Percent Complete Response Rate-12 Months | Up to 12 months | Subjects who are with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma, started the study treatment, and an endometrial biopsy was performed to assess the treatment response, regardless of completion of the study medication. | percentage of participants | NUMBER |
| SECONDARY | Adherence of Treatment | 12 months | Subjects who are with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma, started the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Attributed Adverse Events | Up to 12 months | Subjects who are with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma, started the study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate - 6 Months | Whole Group | 80 | 95% Confidence Interval 52 to 96 | percentage of participants | |
| Complete Response Rate by Group | Complex Atypical Hyperplasia | 100 | 95% Confidence Interval 72 to 100 | percentage of participants | |
| Complete Response Rate by Group | Grade 1 Endometrial Adenocarcinoma | 40 | 95% Confidence Interval 5 to 85 | percentage of participants | |
| Percent Complete Response Rate-12 Months | Complex Atypical Hyperplasia | 100 | 95% Confidence Interval 74 to 100 | percentage of participants | |
| Percent Complete Response Rate-12 Months | Grade 1 Endometrial Adenocarcinoma. | 60 | 95% Confidence Interval 23 to 88 | percentage of participants | |
| Adherence of Treatment | Complex Atypical Hyperplasia | 10 | Participants | ||
| Adherence of Treatment | Grade 1 Endometrial Adenocarcinoma | 7 | Participants | ||
| Treatment Attributed Adverse Events | Complex Atypical Hyperplasia | Abdominal pain Grade1 | 0 | Participants | |
| Treatment Attributed Adverse Events | Grade 1 Endometrial Adenocarcinoma. | Abdominal pain Grade1 | 1 | Participants | |
| Treatment Attributed Adverse Events | Complex Atypical Hyperplasia | Abdominal pain Grade 2 | 0 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study- 12 Months | STARTED | Complex Atypical Hyperplasia | 12 | |
| Overall Study- 12 Months | STARTED | Grade 1 Endometrial Adenocarcinoma | 8 | |
| Overall Study- 12 Months | COMPLETED | Complex Atypical Hyperplasia | 4 | |
| Overall Study- 12 Months | COMPLETED | Grade 1 Endometrial Adenocarcinoma | 6 | |
| Overall Study- 12 Months | NOT COMPLETED | Complex Atypical Hyperplasia | 8 | |
| Overall Study- 12 Months | NOT COMPLETED | Grade 1 Endometrial Adenocarcinoma | 2 | |
| Overall Study -6 Months | STARTED | Complex Atypical Hyperplasia | 12 | |
| Overall Study -6 Months | STARTED | Grade 1 Endometrial Adenocarcinoma | 8 | |
| Overall Study -6 Months | COMPLETED | Complex Atypical Hyperplasia | 7 | |
| Overall Study -6 Months | COMPLETED | Grade 1 Endometrial Adenocarcinoma | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Complex Atypical Hyperplasia | 2 | 12 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Grade 1 Endometrial Adenocarcinoma | 2 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Complex Atypical Hyperplasia | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Grade 1 Endometrial Adenocarcinoma | 2 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | Complex Atypical Hyperplasia | 7 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Grade 1 Endometrial Adenocarcinoma | 4 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Complex Atypical Hyperplasia | 0 | 12 | |
| other | Dyspepsia | Gastrointestinal disorders | Grade 1 Endometrial Adenocarcinoma | 1 | 8 | |
| other | Nausea | Gastrointestinal disorders | Complex Atypical Hyperplasia | 10 | 12 | |
| other | Nausea | Gastrointestinal disorders | Grade 1 Endometrial Adenocarcinoma | 4 | 8 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Complex Atypical Hyperplasia | 0 | 12 |
| Total, all-cause mortality | Grade 1 Endometrial Adenocarcinoma | 0 | 8 |
| Total, other adverse events | Complex Atypical Hyperplasia | 12 | 12 |
| Total, other adverse events | Grade 1 Endometrial Adenocarcinoma | 8 | 8 |
| Total, serious adverse events | Complex Atypical Hyperplasia | 0 | 12 |
| Total, serious adverse events | Grade 1 Endometrial Adenocarcinoma | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Complex Atypical Hyperplasia vs Grade 1 Endometrial Adenocarcinoma: deaths from any cause | Trial comparisons |
| Complex Atypical Hyperplasia vs Grade 1 Endometrial Adenocarcinoma: Adherence of Treatment | Trial comparisons |
| Complex Atypical Hyperplasia vs Grade 1 Endometrial Adenocarcinoma: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02035787
GET https://conductscience.org/api/trials/v1/NCT02035787/results?page=2