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EndometriosisPhase 2NCT05096065

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

A Phase 2 study testing Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B and Leuprolide Oral Tablet - 60 mg - QD - Treatment C in people with Endometriosis, run by Enteris BioPharma Inc. at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B and Leuprolide Oral Tablet - 60 mg - QD - Treatment C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesUnited States
Study dates
18 Mar 2022to May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
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  • 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
  • Administration of any investigational drug and/or experimental device within 30 days prior to the screening visit
  • Administration of any biologics within 30 days prior to the screening visit. Note: The Covid-19 vaccine is not included in this prohibition.
  • Clinically significant finding on the ECG suggesting participation in the study could pose a risk to the subject
  • A depot injection or an implant of any drug within 1 month prior to the screening visit
  • Use of oral contraceptives or other sex steroid hormones within 1 month prior to the screening visit. Note: A 1-month drug holiday period is mandatory for potential subjects receiving GnRH agonists and GnRH antagonists.
  • Any clinically significant physical or gynecological abnormality at the screening visit
  • Any clinically significant abnormal laboratory test result at the screening visit
  • Hemoglobin <11.5 g/dL and/or hematocrit <32%
  • Use of over-the-counter products containing any substances which could have the propensity to impact either estradiol or gonadotropin level
  • Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing
  • History of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors
  • Significant risk factors for decreased bone mineral content and/or bone mass, such as family history (in a first degree relative) of osteoporosis, personal history of chronic use of corticosteroids or anticonvulsants
  • Participation in another drug research within 1 month prior to screening
  • Deemed by the Investigator to have questionable ability to comply with the study protocol, including inadequate adherence to both dosing and use of the AiCure medication adherence monitoring platform during the Run-in Period or during the three Treatment Cycles
  • Current use of any prescription medication known to cause delayed gastric emptying (e.g. glucagon-like peptide-1 receptor agonists)

Trial locations and contacts

4 sites in 1 country.

Gary A. Shangold, M.D. contact

862-261-9113

gshangold@enterisbiopharma.com

Sreeja Polpully Variam, M. Pharma contact

9734533523

svariam@enterisbiopharma.com

United States4 sites, 4 recruiting

  • Complete Healthcare for Women

    Columbus, Ohio, 43231

    Fowzia Maniar, 614-882-5182, fowzia@drsamuel.org

    Recruiting

  • Tidewater Clinical Research

    Norfolk, Virginia, 23502

    April Rusch, 757-471-3375 ext. 1, april.rusch@tidewaterclinresearch.com

    Recruiting

  • Physician Care Clinical Research, LLC

    Sarasota, Florida, 34239

    Debbie M Hays, CCRC, 941-954-2355, dhays@pccrsarasota.com

    Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

    : Dominique Barragan, CCRC, 206-522-3330 ext. 113, dbarragan@seattlewomens.com

    Shann Emerald, 206.522.3330, semerald@seattlewomens.com

    Recruiting

Other trials in United States

About this study

Official title: An Open-label Dose-finding Study to Evaluate the Pharmacodynamic (PD) Profiles and Efficacy of Different Dosing Regimens of Leuprolide Oral Tablets (Ovarest®) in Women With Endometriosis

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.

Read the detailed description

Objectives of this study:

  1. To determine efficacy and pharmacodynamic effects of various dosing regimens of Ovarest® (within the 60-mg - 120 mg daily dosing range) in women with endometriosis.
  2. To determine a minimally effective daily dosing regimen of Ovarest® with pharmacodynamic effects at least comparable to the historical data for marketed Lupron Depot formulations and for GnRH antagonists indicated for the treatment of endometriosis.
  3. To evaluate safety and tolerability of the long-term administration of leuprolide within the targeted daily dosing range in women with endometriosis.

The most important goal of this study is to provide adequate dose-response data for the suppression of estradiol (E2) levels below the menopausal threshold of 20 pg/mL. Results of this study in conjunction of Enteris proprietary PK data will support further development of Leuprolide Acetate Oral Tablet for the treatment of reproductive disorders, particularly endometriosis. Another reason for this trial is to support a comparative evaluation of the PD effects across the QD and BID regimens delivering the same overall dose of Ovarest

Conditions
Endometriosis
Being tested
Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B, Leuprolide Oral Tablet - 60 mg - QD - Treatment C, Leuprolide Oral Tablet - 60 mg - BID - Treatment D, Leuprolide Oral Tablet - 40 mg - BID - Treatment E
Keywords
Leuprolide oral tablets, Endometriosis, pharmacodynamic
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprolide Oral Tablet - 120 mg - QD- Treatment ADrug

    Also called Ovarest® 60 mg

    If the subject during Treatment "A" meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of the First Treatment Cycle), in the Second Treatment Cycle, she will be assigned Treatment "B" - 80 mg (2 x 40 mg tablets) (QD), with food-intake restrictions.

    If the subject during Treatment "A" fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the First Treatment Cycle), then she will be switched to the Second Treatment Cycle with Treatment "D" - 60 mg (BID) with food intake restrictions.

  • Leuprolide Oral Tablet - 80 mg - QD - Treatment BDrug

    Also called Ovarest® 40 mg

    If the subject on Treatment "B" meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "C" - 60 mg (QD) with food-intake restrictions.

    If the subject on Treatment "B" does not meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "E" - 40 mg (BID) with food intake restrictions.

  • Leuprolide Oral Tablet - 60 mg - QD - Treatment CDrug

    Also called Ovarest® 60 mg

    For up to 29 consecutive days with food-intake restrictions

  • Leuprolide Oral Tablet - 60 mg - BID - Treatment DDrug

    Also called Ovarest® 60 mg

    If the subject on Treatment "D" fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), she will be discontinued from the study following completion of the Second Treatment Cycle.

    If the subject during Treatment "D" meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of her Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "E" - 40 mg (BID) with food intake restrictions.

  • Leuprolide Oral Tablet - 40 mg - BID - Treatment EDrug

    Also called Ovarest® 40 mg

    For up to 29 consecutive days with food-intake restrictions

Study groups in NCT05096065
Study groupRoleWhat they receive
Treatment A: Leuprolide Oral Tablet, 120 mg QDExperimentalLeuprolide Oral Tablet (Ovarest), 120 mg (2 x 60 mg tablets), administered once daily (QD), for up to 35 consecutive days with food-intake restrictions.
Receives: Drug: Leuprolide Oral Tablet - 120 mg - QD- Treatment A
Treatment B: Leuprolide Oral Tablet, 80 mg QDExperimentalLeuprolide Oral Tablet (Ovarest), 80 mg (2 x 40 mg tablets), administered once daily (QD) for up to 35 consecutive days with food-intake restrictions.
Receives: Drug: Leuprolide Oral Tablet - 80 mg - QD - Treatment B
Treatment C: Leuprolide Oral Tablet, 60 mg QDExperimentalLeuprolide Oral Tablet (Ovarest), 60 mg, administered once daily (QD) for up to 29 consecutive days with food-intake restrictions.
Receives: Drug: Leuprolide Oral Tablet - 60 mg - QD - Treatment C
Treatment D: Leuprolide Oral Tablet, 60 mg BIDExperimentalLeuprolide Oral Tablet (Ovarest), 60 mg, administered twice daily (BID), 12 hours apart for up to 35 consecutive days with food-intake restrictions.
Receives: Drug: Leuprolide Oral Tablet - 60 mg - BID - Treatment D
Treatment E:Leuprolide Oral Tablet (Ovarest), 40 mg BIDExperimentalLeuprolide Oral Tablet (Ovarest), 40 mg, administered twice daily (BID), 12 hours apart for up to 29 consecutive days with food-intake restrictions.
Receives: Drug: Leuprolide Oral Tablet - 40 mg - BID - Treatment E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL

    The primary PD metric - suppression of E2 level (E2 <20 pg/mL) - will be assessed at each on-treatment evaluation timepoint. E2 below 20 pg/mL at Day 29 is a primary endpoint for a given Treatment Cycle.

    Measured: Treatment cycle: Day 29

Secondary outcomes (6)

  1. Suppression of ovulation (as evidenced by progesterone levels <3 ng/mL)

    It will be evaluated with Treatment Cycle Day 22 and Treatment Cycle Day 29 (separately and combined) positioned as most important timepoints for this analyte.

    Measured: Treatment cycle: Day 22 and 29

  2. Number of vaginal (menstrual) bleeding days

    The onset of menstrual period is defined as at least three consecutive bleeding/spotting days during the 14-day postdosing period.

    Measured: 28 days of therapy and 14 days post study follow up

  3. Composite Pelvic Signs and Symptoms (CPSS) scores

    CPSS scores (composite and for the individual items) and changes from the pre-dosing baseline will be summarized by treatment received. CPSSS values are derived from the Biberoglu and Behrman scale, with 5 components addressing dysmenorrhea (0-none and 3-severe), dyspareunia (0-none and 3-severe), non-menstrual pelvic pain (0-none and 3-severe), pelvic tenderness (0-none and 3-severe), and pelvic induration (0-none and 3-severe). In composite score (total symptom and sign severity score) 0 being none and 11-15 being very severe.

    Measured: Treatment day 29

  4. (Pre-dose leuprolide level) Subject incidence of Leuprolide below detectable level

    The summaries will be provided for each PK evaluation timepoint and across the entire treatment cycle

    Measured: Treatment Cycle: Days 1, 8, 15, 22 and 29 days

  5. Luteinizing hormone (LH) levels

    Serum concentration measured immediately prior to dosing

    Measured: Treatment days: 1,8, 15, 22 and 29; Post dosing day 14

  6. Follicle Stimulating Hormone (FSH) levels

    Serum concentration measured immediately prior to dosing

    Measured: Treatment days: 1,8, 15, 22 and 29; Post dosing day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start18 Mar 2022
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096065
Sponsor's protocol ID
LOPDT-ENDO-02
Status last verified
Mar 2022
First submitted
15 Oct 2021
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B and Leuprolide Oral Tablet - 60 mg - QD - Treatment C in people with Endometriosis, run by Enteris BioPharma Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gary A. Shangold, M.D. (862-261-9113, gshangold@enterisbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL (time frame: Treatment cycle: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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