Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis

Status unconfirmed · Phase 2

Conditions studied: Endometriosis

In brief

The pharmacodynamic endpoint of percentage of subjects with suppressed estradiol level (less than 20 pg/mL) on cycle day 29 is the primary endpoint of the study.

Key facts

Study ID: NCT05096065
Run by: Enteris BioPharma Inc.
People needed: 16
Starts: 2022-03-18
Expected to finish: 2022-05-01
Last updated by the study team: 2022-03-22

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women diagnosed with endometriosis and having pelvic pain, both treatment naive or previously treated with GnRH agonists or antagonists with improvement
Premenopausal females in general good health, including absence of current COVID infection (positive test or presence of symptoms), aged 18 to 49 years
BMI ≥18 and ≤35 kg/m2, and weight ≥110 lb. (≈50 kg).
A documented estradiol level ≥ 40 pg/mL at screening or on retest
Regular menstrual cycles with a usual length ranging from 21 days to 35 days. If subject has recently used hormonal birth control, historical data prior to use will be used to determine qualification and must also meet this criterion.
If of childbearing potential and sexually active with a risk of pregnancy, willing to use acceptable methods of contraception (Note: acceptable methods of contraception are specified in Section 8.1)
Willing to refrain from excessive use of alcohol during the entire study and willing to refrain from use of alcohol 24 hours prior to any PK blood draw taken during the study
Willing to refrain from the use of any hormone-containing or hormone-altering substances during the study.
Willing and able to adhere to medication schedule and to utilize the AiCure medication adherence monitoring platform correctly with the administration of each dose of medication throughout the duration of the 3 treatment cycles comprising this study
Willing and capable to give informed consent to participate in study

You may not qualify if…

Subjects to whom any of the following applies will be excluded from the study:
Hypersensitivity to GnRH, GnRH agonist analogs, similar nonapeptides, or any of the excipients in LUPRON DEPOT. Note: This is a contraindication from the Lupron Depot label.
Undiagnosed abnormal vaginal bleeding. Note: This is a contraindication from the Lupron Depot label.
Known or suspected pregnancy, or subjects who are considering becoming pregnant prior to the conclusion of this study. Note: LUPRON DEPOT is contraindicated in women who are or may become pregnant while receiving the drug. LUPRON DEPOT may cause fetal harm when administered to a pregnant woman…. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Breastfeeding or within 2 months after stopping breastfeeding (relative to the screening visit). Note: Use of LUPRON DEPOT is contraindicated in women who are breastfeeding.
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions. Note: Per the LUPRON DEPOT label, a possible coadministration of norethindrone acetate is contraindicated in women with thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions.
Markedly impaired liver function or liver disease. Note: Per the LUPRON DEPOT label, a possible coadministration of norethindrone acetate is contraindicated in women with markedly impaired liver function or liver disease.
Known or suspected carcinoma of the breast. Note: Per the LUPRON DEPOT label, a possible coadministration of norethindrone acetate is contraindicated in women with known or suspected carcinoma of the breast.
Status postpartum or postabortion within a period of 2 months prior to the screening visit
History of significant alcohol or drug abuse within one year prior to the screening visit
Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mm Hg, diastolic blood pressure lower than 50 or over 90 mm Hg, or heart rate less than 50 or over 100 bpm) at screening (following recheck after five minutes at rest)
Any clinically significant history or presence of neurologic, endocrinologic, pulmonary, hematologic, immunologic, or metabolic disease
History of severe respiratory depression or pulmonary insufficiency
Diabetes mellitus requiring insulin
History of headaches with focal neurological symptoms
Uncontrolled thyroid disorder
Sickle cell anemia
Current or history of clinically significant depression in the last year
Known disturbance of lipid metabolism
Hepatic adenoma or carcinoma
Known or suspected endometrial carcinoma or estrogen-dependent neoplasia
Clinically significant history or presence of any gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel diseases, history of cholecystectomy), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting) or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug
Difficulty in swallowing study medication
Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study
Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening

Where it is running

Physician Care Clinical Research, LLC — Sarasota, Florida, United States (enrolling)
Complete Healthcare for Women — Columbus, Ohio, United States (enrolling)
Tidewater Clinical Research — Norfolk, Virginia, United States (enrolling)
Seattle Clinical Research Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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