EndometriosisPhase 2NCT02807363
A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
A Phase 2 study testing Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID and Leuprolide Depot in people with Endometriosis, run by Enteris BioPharma Inc. at 1 site in Canada.
Trial summary
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens and 10 mg oral tablets administered over 28… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID and Leuprolide Depot
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2017to 27 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy premenopausal female volunteers, aged 18 to 49 years;
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2, and weight ≥ 110 lb (approximately 50 kg);
- Regular menstrual cycles with a usual length ranging from 21 days to 35 days. If subject had recently used hormonal birth control, historical data prior to use were 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 one of the following acceptable methods of contraception throughout the study and for at least 30 days after the last drug administration:
- intrauterine contraceptive device (IUD) without hormone release system placed at least 4 weeks prior to the first study drug administration with simultaneous use of condom for the male partner;
- simultaneous use of diaphragm with intravaginally applied spermicide and condom for the male partner starting at least 14 days prior to drug administration;
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- sterile male partner (vasectomized for at least 6 months); Note: Surgically sterile subjects who have had a tubal ligation were considered of non-childbearing potential and were not required to use contraception;
- 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 use of prescription medications, over-the-counter medications, and natural health products during the entire study;
- Willing and capable to give informed consent to participate in study.
Who cannot join
- Hypersensitivity to GnRH, GnRH agonist analogs, similar nonapeptides, or any of the excipients in Lupron Depot®. Note: This was a contraindication from the Lupron Depot® label;
- Undiagnosed abnormal vaginal bleeding. Note: This was a contraindication from the Lupron Depot® label;
- Known or suspected pregnancy, or subjects who were considered to become pregnant prior to the conclusion of this study. Note: Lupron Depot® was contraindicated in women who were or may become pregnant while receiving the drug. Lupron Depot® could cause fetal harm when administered to a pregnant woman. If this drug was 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® was contraindicated in women who were 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 was 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 co-administration of norethindrone acetate was contraindicated in women with markedly impaired liver function or liver disease;
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- Known or suspected carcinoma of the breast. Note: Per the Lupron Depot® label, a possible co-administration of norethindrone acetate was contraindicated in women with known or suspected carcinoma of the breast;
- Status postpartum or post-abortion within a period of 2 months prior to the Screening visit;
- A cervical cytology smear of Papanicolaou (Pap) Class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater (Pap smear results within last 12 months were acceptable if properly documented);
- Use of any tobacco products (including electronic cigarettes) in the 3 months preceding the Screening visit or positive urine cotinine test at Screening;
- History of significant alcohol or drug abuse within 1 year prior to the Screening visit;
- Clinically significant (CS) vital sign abnormalities (systolic blood pressure [BP] lower than 90 or over 140 mm Hg, diastolic BP lower than 50 or over 90 mm Hg, or heart rate less than 50 or over 100 bpm) at Screening;
- Any CS 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 CS 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), 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 90 days prior to the Screening visit;
- Clinically significant finding on the electrocardiogram (ECG) suggesting participation in the study could pose a risk to the subject;
- A depot injection or an implant of any drug within 6 months prior to the Screening visit;
- Use of oral contraceptives or other sex steroid hormones within 3 months prior to the Screening visit;
- Any CS physical or gynecological abnormality at the Screening visit;
- Any CS abnormal laboratory test result at the Screening visit;
- Hemoglobin < 115 g/L and/or hematocrit < 0.32 L/L;
- Use of prescription medication within 14 days prior to the first administration of study medication or over-the-counter (OTC) products (including natural health products; e.g., food supplements, vitamins, herbal supplements) within 7 days prior to the first administration of study medication, except for topical products without significant systemic absorption;
- 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;
- Deemed by the Investigator to have questionable ability to comply with the study protocol;
- History of seizures, epilepsy, cerebrovascular disorders, central nervous system (CNS) 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel-group, Active-control PK/PD Study of Three Doses of Leuprolide Oral Tablets in Comparison to an IM Dose of Leuprolide in Healthy Female Volunteers
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and cessation of the menstrual period) will also be evaluated against the Lupron Depot historical data.
Read the detailed description
Site initiation visit of the study site, InVentiv Health Clinique, Inc. by on-site visit and teleconference was done and the final report signed 21st July 2017.
For the demographic and baseline characteristics descriptive statistics consisting of mean, median, standard deviation, minimum, maximum and sample size is reported for continuous variables like age, body mass index, weight and height. categorical variables like ethnicity, gender and race is presented as frequency counts and percentages.
For PK analysis, Steady state concentration level of leuprolide calculated for oral tablets (Treatments A and B) at the end of the fourth treatment week (Treatment Days 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e., 24 hours.
For PD analysis, subject incidence of estradiol level below 40 pg/mL was assessed. The ovulation rate determined by the extent of progesterone suppression is presented.
Only observed data is used in the data analysis except for concentration values below the lower limit of quantitation (BLQ) and samples with no reportable value occurring prior to dosing (on Day 1 only). No attempt is made to impute (i.e., extrapolate or interpolate) estimates for missing data.
For safety analysis, incidence of treatment emergent adverse events both during the dosing and post dosing period is presented.
The Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.1 is used to classify all medical history findings and incidences of treatment emergent adverse events (TEAE) reported during the study by System Organ Class (SOC) and Preferred Term (PT).
- Conditions
- Endometriosis
- Being tested
- Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID, Leuprolide Depot, Leuprolide Oral Tablet 10-mg BID
- Keywords
- endometriosis, gonadotropin-releasing hormone agonist, healthy volunteers, leuprolide oral tablet
- 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 4-mg QDDrug
Also called Ovarest™ 4.0 mg
4-mg Leuprolide oral tablet once daily for 28 consecutive days.
Leuprolide Oral Tablet 4-mg BIDDrug
Also called Ovarest™ 4.0 mg
4-mg Leuprolide oral tablet twice daily for 28 consecutive days.
Leuprolide DepotDrug
Also called Lupron Depot® 3.75 mg
3.75 mg intramuscular depot injection
Leuprolide Oral Tablet 10-mg BIDDrug
Also called Ovarest™ 10.0 mg
10-mg Leuprolide oral tablet twice daily for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Leuprolide Oral Tablet, 4 mg QD | Experimental | Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days. Receives: Drug: Leuprolide Oral Tablet 4-mg QD |
| Treatment B: Leuprolide Oral Tablet, 4 mg BID | Experimental | Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days. Receives: Drug: Leuprolide Oral Tablet 4-mg BID |
| Treatment C: Leuprolide 1 month depot | Active comparator | Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy Receives: Drug: Leuprolide Depot |
| Treatment D: Leuprolide Oral Tablet, 10 mg BID | Experimental | Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days Receives: Drug: Leuprolide Oral Tablet 10-mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL
Criterion: E2 level is considered suppressed during the evaluation period if a value below pre-specified threshold was reported at least once during that period.
The days in the row title indicate the evaluation interval.
Measured: Dosing Period: Day 8 to 28, Post-dosing: Day 1 to day 28 of post dosing period; Day 29 is the post dosing day 1
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL
Progesterone level is considered suppressed during the evaluation period if a value below pre-specified threshold (3000 pg/mL) was reported at least once during that period.
The days in row title indicate the evaluation interval.
Measured: Dosing period: Day 1 to Day 28 and 28 day Post-Dosing Period; 29 day is post dosing day 1
Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAE) Excluding Menstrual Disorders
The participant incidence of TEAEs was generally comparable during the dosing period across the treatment groups.
Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for adverse event was collected for day 1 to 28 of the dosing period.
Measured: Dosing Period: Day 1 to day 28
Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs), Excluding Menstrual Disorders
Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for post dosing adverse event was collected starting from day 1 to 28 post the 28th day of dosing.
Measured: Post dosing period (starting day 1 to day 28 post dosing period)
Steady State Concentration Level, (Css) of Leuprolide
Treatment A and B: Steady state concentration level calculated for oral tablets at the end of the fourth treatment week (Treatment Day 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e. 24 hours.
Treatment C: Steady state concentration level calculated for IM injection at the fourth treatment week (a mean of leuprolide levels on Days 22 and 29).
Measured: Treatment Day 28 for oral groups; Treatment Days 22-29 for Lupron Depot group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start23 Aug 2017
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enteris BioPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Gary Shangold, MD, Study chair, Enteris BioPharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807363
- Sponsor's protocol ID
- LOPDT-ENDO-01
- Status last verified
- Jan 2022
- First submitted
- 14 Jun 2016
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-group, Active-control PK/PD Study of Three Doses of Leuprolide Oral Tablets in Comparison to an IM Dose of Leuprolide in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT02807363
- Acronym / sponsor ID
- LOPDT-ENDO-01
- Conditions
- Endometriosis
- Keywords
- endometriosis, gonadotropin-releasing hormone agonist, healthy volunteers, leuprolide oral tablet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Enteris BioPharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and cessation of the menstrual period) will also be evaluated against the Lupron Depot historical data.
Detailed description
Site initiation visit of the study site, InVentiv Health Clinique, Inc. by on-site visit and teleconference was done and the final report signed 21st July 2017.
For the demographic and baseline characteristics descriptive statistics consisting of mean, median, standard deviation, minimum, maximum and sample size is reported for continuous variables like age, body mass index, weight and height. categorical variables like ethnicity, gender and race is presented as frequency counts and percentages.
For PK analysis, Steady state concentration level of leuprolide calculated for oral tablets (Treatments A and B) at the end of the fourth treatment week (Treatment Days 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e., 24 hours.
For PD analysis, subject incidence of estradiol level below 40 pg/mL was assessed. The ovulation rate determined by the extent of progesterone suppression is presented.
Only observed data is used in the data analysis except for concentration values below the lower limit of quantitation (BLQ) and samples with no reportable value occurring prior to dosing (on Day 1 only). No attempt is made to impute (i.e., extrapolate or interpolate) estimates for missing data.
For safety analysis, incidence of treatment emergent adverse events both during the dosing and post dosing period is presented.
The Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.1 is used to classify all medical history findings and incidences of treatment emergent adverse events (TEAE) reported during the study by System Organ Class (SOC) and Preferred Term (PT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Leuprolide Oral Tablet, 4 mg QD | Experimental | Drug: Leuprolide Oral Tablet 4-mg QDLeuprolide Oral Tablet QD: 4 mg for 28 consecutive days. |
| Treatment B: Leuprolide Oral Tablet, 4 mg BID | Experimental | Drug: Leuprolide Oral Tablet 4-mg BIDLeuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days. |
| Treatment C: Leuprolide 1 month depot | Active comparator | Drug: Leuprolide DepotLeuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy |
| Treatment D: Leuprolide Oral Tablet, 10 mg BID | Experimental | Drug: Leuprolide Oral Tablet 10-mg BIDLeuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy premenopausal female volunteers, aged 18 to 49 years;
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2, and weight ≥ 110 lb (approximately 50 kg);
- Regular menstrual cycles with a usual length ranging from 21 days to 35 days. If subject had recently used hormonal birth control, historical data prior to use were 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 one of the following acceptable methods of contraception throughout the study and for at least 30 days after the last drug administration:
- 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;
Key exclusion criteria (39 listed)
- Hypersensitivity to GnRH, GnRH agonist analogs, similar nonapeptides, or any of the excipients in Lupron Depot®. Note: This was a contraindication from the Lupron Depot® label;
- Undiagnosed abnormal vaginal bleeding. Note: This was a contraindication from the Lupron Depot® label;
- Known or suspected pregnancy, or subjects who were considered to become pregnant prior to the conclusion of this study. Note: Lupron Depot® was contraindicated in women who were or may become pregnant while receiving the drug. Lupron Depot® could cause fetal harm when administered to a pregnant woman. If this drug was 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® was contraindicated in women who were 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 was contraindicated in women with thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprolide Oral Tablet 4-mg QDAlso: Ovarest™ 4.0 mg4-mg Leuprolide oral tablet once daily for 28 consecutive days. | Drug | Treatment A: Leuprolide Oral Tablet, 4 mg QD |
| Leuprolide Oral Tablet 4-mg BIDAlso: Ovarest™ 4.0 mg4-mg Leuprolide oral tablet twice daily for 28 consecutive days. | Drug | Treatment B: Leuprolide Oral Tablet, 4 mg BID |
| Leuprolide DepotAlso: Lupron Depot® 3.75 mg3.75 mg intramuscular depot injection | Drug | Treatment C: Leuprolide 1 month depot |
| Leuprolide Oral Tablet 10-mg BIDAlso: Ovarest™ 10.0 mg10-mg Leuprolide oral tablet twice daily for 28 consecutive days. | Drug | Treatment D: Leuprolide Oral Tablet, 10 mg BID |
Primary outcome
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL
Time frame: Dosing Period: Day 8 to 28, Post-dosing: Day 1 to day 28 of post dosing period; Day 29 is the post dosing day 1
Criterion: E2 level is considered suppressed during the evaluation period if a value below pre-specified threshold was reported at least once during that period. The days in the row title indicate the evaluation interval.
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL
Time frame: Dosing period: Day 1 to Day 28 and 28 day Post-Dosing Period; 29 day is post dosing day 1
Progesterone level is considered suppressed during the evaluation period if a value below pre-specified threshold (3000 pg/mL) was reported at least once during that period. The days in row title indicate the evaluation interval.
Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAE) Excluding Menstrual Disorders
Time frame: Dosing Period: Day 1 to day 28
The participant incidence of TEAEs was generally comparable during the dosing period across the treatment groups. Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for adverse event was collected for day 1 to 28 of the dosing period.
Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs), Excluding Menstrual Disorders
Time frame: Post dosing period (starting day 1 to day 28 post dosing period)
Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for post dosing adverse event was collected starting from day 1 to 28 post the 28th day of dosing.
Steady State Concentration Level, (Css) of Leuprolide
Time frame: Treatment Day 28 for oral groups; Treatment Days 22-29 for Lupron Depot group
Treatment A and B: Steady state concentration level calculated for oral tablets at the end of the fourth treatment week (Treatment Day 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e. 24 hours. Treatment C: Steady state concentration level calculated for IM injection at the fourth treatment week (a mean of leuprolide levels on Days 22 and 29).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Shangold, MD study chair
Enteris BioPharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID and Leuprolide Depot in people with Endometriosis, run by Enteris BioPharma Inc. at 1 site in Canada.
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 39 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: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL (time frame: Dosing Period: Day 8 to 28, Post-dosing: Day 1 to day 28 of post dosing period; Day 29 is the post dosing day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2022.