Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01943058
Eligibility Criteria:
Inclusion Criteria:
* A histologic diagnosis of complex atypical hyperplasia or grade 1 endometrioid adenocarcinoma of the endometrium diagnoses within 3 months of study enrollment who strongly desire to maintain fertility
* A diagnosis of endometrioid adenocarcinoma will undergo a magnetic resonance imaging (MRI) scan of the pelvis to rule out deep (\> 50%) myometrial invasion and extrauterine metastases
* A negative urine or serum pregnancy test at the time of enrollment
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Willing and able to consent for treatment with office endometrial biopsies every 3 months
* Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* A diagnosis of grade 1 endometrioid adenocarcinoma of the endometrium who does not wish to maintain fertility
* MRI evidence of deep myometrial and/or extrauterine spread
* Congenital or other structural uterine or tubal abnormality
* An acute pelvic inflammatory disease or medical conditions, such as, but not limited to acquired immunodeficiency syndrome (AIDS) and chronic immunosuppression, that may be associated with an increased susceptibility to infections
* Current diagnosis of breast cancer or any other cancer
* Currently pregnant or breastfeeding
* Thromboembolic disease, deep vein thrombosis, hypercoagulable state
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01943058
Study Brief:
Protocol Section:
NCT01943058