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    Summary
    EudraCT Number:2016-002179-91
    Sponsor's Protocol Code Number:MLE4901-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-002179-91
    A.3Full title of the trial
    A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study of an investigational drug, MLE4901, for the treatment of Polycystic Ovary Syndrome (PCOS).
    A.4.1Sponsor's protocol code numberMLE4901-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02865915
    A.5.4Other Identifiers
    Name:US IND NumberNumber:116350
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMillendo Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMillendo Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Finland OY
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressKarjalankatu 2, 4 Krs
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00520
    B.5.3.4CountryFinland
    B.5.4Telephone number4670 252 4055
    B.5.5Fax number4689 6702 100
    B.5.6E-mailregsubmissions@medpace.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MLE4901
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available yet
    D.3.9.1CAS number 941690-55-7
    D.3.9.2Current sponsor codeMLE4901
    D.3.9.3Other descriptive nameAZD4901, AZD2624, AZ12472520
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeN-acyl-triazolopiperazine NKᴈ Receptor Antagonist
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polycystic Ovary Syndrome
    E.1.1.1Medical condition in easily understood language
    Irregular hormone levels causing enlarged ovaries due to multiple small collections of fluid within the ovary. Some symptoms include infrequent menstrual periods, excess hair growth, acne.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065161
    E.1.2Term Polycystic ovarian syndrome
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out whether MLE4901 works to improve menstrual regularity in women with infrequent menstrual periods due to Polycystic Ovary Syndrome (PCOS)
    E.2.2Secondary objectives of the trial
    • To find out whether MLE4901 improves the following over 28 weeks of treatment:
    ○ ovulation regularity
    ○ the Most Bothersome Symptom of PCOS
    ○ hormone levels (including testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), LH/FSH,
    estradiol, progesterone and anti-Müllerian hormone (AMH))
    ○ symptoms of increased male hormones such as excess facial and body hair, acne and hair thinning or baldness
    • To determine the durability of MLE4901 effects during the 8-week Follow-up Period
    • To explore the impact of MLE4901 on measures of health-related quality of life and work productivity
    • To assess the safety and tolerability of MLE4901
    • To determine the pharmacokinetic (PK) parameters of MLE4901 and its major metabolites
    • To evaluate the blood levels of MLE4901
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent prior to any study-specific procedures
    2. Women 18 to 45 years of age (inclusive)
    3. Oligo-/amenorrhea defined as ≤6 menstrual cycles per year off of any hormone therapy (may be based on subject historical recall)
    4. At least one of the following during Screening:
    • Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
    • Biochemical hyperandrogenism defined as an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
    • Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume >10 mL (without a cyst or dominant follicle) in either ovary
    5. Body mass index (BMI) 22 to 45 kg/m2, inclusive
    6. Must be willing to avoid use of all hair removal procedures (e.g., electrolysis, laser hair removal, plucking/tweezing, waxing, threading, etc.) and products (e.g., Vaniqa®, Nair™, etc.) during study participation in the areas of the scalp, upper lip, chin, chest, back, abdomen, upper arms and thighs
    Note: Shaving is allowed; however, subjects must not shave within 72 hours prior to visits S1, T1 and T7 to permit assessment of hair growth
    7. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
    8. Must be willing to avoid the use of all hair growth procedures (e.g., hair transplant) and products (e.g., minoxidil (Rogaine®)) during study participation
    9. Must be willing to avoid the use of all of the other prohibited medications (including metformin, oral contraceptives, clomiphene, letrozole, spironolactone, finasteride and flutamide) and procedures during study participation (Sections 5.12, 5.13 and 5.14)
    10. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) >2 years or male partner(s) has had a vasectomy >2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide,
    diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.
    11. Must agree to not attempt to conceive during participation in the study
    E.4Principal exclusion criteria
    1. Menopausal or peri-menopausal, defined for this study as FSH >10 IU/L
    2. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
    3. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test (Note: Results from a Pap test performed within 1 year prior to Screening may be used)
    4. Uncontrolled hypo- or hyperthyroidism, defined as having an abnormal TSH during Screening or Lead-in and/or change in thyroid medication dose within the month prior to Screening
    5. Any suspected cause of hirsutism, acne, or alopecia other than PCOS
    6. Post-hysterectomy or endometrial ablation
    7. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
    8. No menstrual periods during Lead-in (i.e., failed progestin challenge)
    9. Two or more menstrual periods during Lead-in
    10. Use of any of the following medications within 28 days prior to the start of Lead-in:
    • Metformin or other insulin-sensitizing medications (e.g., rosiglitazone, pioglitazone, etc.)
    • Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.)
    • Hormone-releasing intrauterine device
    • Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
    • Clomiphene citrate or estrogen modulators such as letrozole
    • GnRH modulators such as leuprolide
    • Minoxidil
    Note: Women who received every-3-month progestin challenge and no other hormonal therapy during the year prior to Screening and who did not have any menstrual bleeding other than that due to withdrawal from progestin challenge, may be randomized (if they meet all other inclusion/exclusion criteria) into the <4 menstrual cycles per year stratum.
    11. Medical requirement for any of the prohibited concomitant medications
    12. Medical history of type 1 or type 2 diabetes mellitus
    13. Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg
    14. Any history of gastric or small intestinal surgery or any current disease that causes malabsorption
    15. Alcohol or substance abuse (cocaine, amphetamines and/or opioids) within the year prior to Screening
    16. Abnormal laboratory values as per the guidelines listed below or any other clinically significant, unexplained laboratory abnormality according to the Investigator:
    • ALT or AST >2 times ULN
    • Total bilirubin >1.5 times ULN
    • Creatinine >1.5 times ULN
    • Fasting glucose >126 mg/dL (6.99 mmol/L)
    • Hemoglobin A1c >6.5%
    • Prolactin >ULN
    • 17-hydroxyprogesterone >200 ng/dL (6nmol/L)
    • Total testosterone >150 ng/dL (5.21 nmol/L)
    • DHEA-S >800 μg/dL (21.6 μmol/L)
    • TSH >ULN or <LLN
    17. Currently pregnant or breastfeeding or having conceived within the 3 months prior to Screening
    18. QTc >470 msec on electrocardiogram at Screening or at Visit T1 (subjects with a single QTc >470 msec may have 2 additional ECGs taken and the QTcs averaged; if the average QTc is >470 msec then the subject is excluded)
    19. History of Gilbert’s syndrome
    20. HIV, hepatitis B, or hepatitis C positivity
    21. Any malignancy within the previous 10 years, other than curatively resected basal or squamous cell skin cancer
    22. Previous receipt of any amount of AZD4901 or AZD2624
    23. Participation in any study of an investigational drug or device or investigational biological agent within 30 days (or 5 half-lives of the investigational agent, whichever is longer) prior to Screening
    24. Any other medical or psychiatric condition (e.g., uncontrolled sleep apnea, severe depression, etc.) that, in the opinion of the Investigator, is likely to confound the interpretation of the study results or prevent the subject from understanding the requirements of or successfully completing the study
    E.5 End points
    E.5.1Primary end point(s)
    The change in the duration of menstrual cycles from Baseline to End-of-Treatment (EoT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to End-of-Treatment (EoT)
    E.5.2Secondary end point(s)
    The number of menstrual periods during the Treatment Period
    • The duration of menstrual cycles over the Treatment Period
    • The change from Baseline in the duration of each menstrual cycle over the Treatment Period
    • The change in the ovulation interval from Baseline to EoT
    • The number of ovulations during the Treatment Period
    • The duration of ovulation intervals over the Treatment Period
    • The change from Baseline in the ovulation interval for each ovulation over the Treatment Period
    • The time from the start of the last menstrual period prior to randomization to the first menstrual period after randomization
    • The time to the first normal menstrual cycle duration
    • The number of consecutive menstrual cycles of 21-35 days’ duration over the Treatment Period
    • The time from the last ovulation prior to randomization (or first dose of MPA, if no ovulation during Lead-in) to the first ovulation after randomization
    • The time to the first normal ovulation interval
    • The number of consecutive ovulation intervals of 21-35 days’ duration over the Treatment Period
    • The proportion of subjects with at least 4 self-reported menstrual periods over the Treatment Period
    • The proportion of subjects having menstrual cycles of 21-35 days’ duration for a continuous 6-month period during the Treatment Period
    • The proportion of subjects having menstrual bleeding of 2-7 days’ duration for a continuous 6-month period during the Treatment Period
    • The proportion of subjects with normal menstrual cycles for a continuous 6-month period during the Treatment Period
    • The change from Baseline in the severity of the subjects’ self-identified Most Bothersome Symptom of PCOS
    • The change from Baseline in the severity of each symptom of PCOS (oligo-/amenorrhea, hirsutism, acne and alopecia)
    • The change from Baseline in testosterone (total, free and bioavailable), LH, FSH, LH/FSH, estradiol, progesterone and AMH
    • The change from Baseline in the modified Ferriman-Gallwey score for hirsutism
    • The change from Baseline in the Investigator’s Static Global Assessment of acne score
    • The change from Baseline in the Savin score for androgenic alopecia
    • The change from Baseline in fasting glucose, insulin, total cholesterol, LDL, HDL and triglycerides
    • The change from Baseline in systolic blood pressure, diastolic blood pressure and body mass index
    • The duration of menstrual cycles over the Follow-up Period
    • The duration of ovulation intervals over the Follow-up Period
    • The change from Baseline in the frequency of removal of unwanted hair from the upper lip and chin
    • The change from Baseline in the domain scores on the mPCOSQ
    • The change from Baseline in the score on the EQ-5D-5L health state survey
    • The change from Baseline in the domain scores on the Work Productivity and Activity Impairment: General Health Questionnaire (WPAI:GH)
    • The change from Baseline in the mean total score, anxiety subscale score and depression subscale score on the PHQ-4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to End-of-Treatment (EoT)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-blind, Randomized, Parallel-group, Placebo-controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After participation in the trial, the decision on patient treatment will be at the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-10
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