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    Summary
    EudraCT Number:2019-003468-27
    Sponsor's Protocol Code Number:PiNCv.1.1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-10-03
    Trial 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 number2019-003468-27
    A.3Full title of the trial
    A Randomised Controlled trial investigating the effects of Progesterone for luteal phase support in Natural Cycles for unexplained infertility
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating whether progesterone supplementation in otherwise unmedicated, natural menstrual cycles can improve live birth rates
    A.3.2Name or abbreviated title of the trial where available
    Progesterone in Natural Cycles (PiNC)
    A.4.1Sponsor's protocol code numberPiNCv.1.1
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1239-3871
    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 SponsorHomerton University Hospital NHS Trust
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLD Collins & Co. Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSPD Development Company Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHomerton University Hospital
    B.5.2Functional name of contact pointDr Claudia Raperport
    B.5.3 Address:
    B.5.3.1Street AddressFertility Unit, Homerton University Hospital, Homerton Row
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE9 6SR
    B.5.4Telephone number07833666644
    B.5.6E-mailclaudia.r@doctors.org.uk
    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 Yes
    D.2.1.1.1Trade name Cyclogest
    D.2.1.1.2Name of the Marketing Authorisation holderLD Collins
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameCyclogest
    D.3.4Pharmaceutical form Pessary
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    Vaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNProgesterone
    D.3.9.1CAS number 57-83-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unexplained infertility
    E.1.1.1Medical condition in easily understood language
    Couples having difficulty conceiving despite normal test results
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049513
    E.1.2Term Luteal phase deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does progesterone supplementation in otherwise un-medicated, natural menstrual cycles for women with unexplained infertility improve their chances of having a live birth?
    E.2.2Secondary objectives of the trial
    Does treatment with extra progesterone hormone in otherwise natural menstrual cycles for women with unexplained infertility increase their progesterone levels and/or improve their chances of conceiving a pregnancy?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female:
    • bilateral patent tubes within last 12 months (HSG/HyCoSy/Laparoscopy)
    • Ovulation as defined by regular cycles or ultrasound appearance of either a corpus luteum or dominant follicle or midluteal progesterone over 30nmol/ml
    • Regular intercourse and failure to conceive for at least 12 months
    Willingness to participate, disclose personal data and provide written consent
    Male:
    • Semen analysis with:
    • >15 mil/ml concentration
    • Motility over 40%
    • Progressive motility over 32%
    • ≥ 4% normal forms
    • No erectile dysfunction or other problem preventing penetrative intercourse
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Age ≥42 years
    • Unilateral tubal patency
    • BMI ≥30
    • Abnormal uterine cavity as seen on ultrasound
    • History of Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis.
    • Undiagnosed vaginal bleeding
    • Known or suspected progesterone sensitive malignant tumours
    • Porphyria
    • Severe hepatic dysfunction or disease
    • Known missed abortion or ectopic pregnancy or missed miscarriage (if these are diagnosed during the trial any Cyclogest being used will be discontinued by the clinical team)
    • Hypersensitivity to the active substance or vegetable fat.
    • Diabetes Mellitus
    E.5 End points
    E.5.1Primary end point(s)
    Live Birth Rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of trial
    E.5.2Secondary end point(s)
    Biochemical pregnancy rates (positive urine HCG test at least 14 days after starting progesterone)
    Clinical pregnancy (intrauterine gestational sac confirmed on ultrasound at 6-8 weeks gestation)
    Mid-luteal serum progesterone levels

    Clinical efficacy outcomes/clinical safety outcomes:

    Miscarriage and ectopic pregnancy rates
    Stillbirth (pregnancy loss after 24 weeks of gestation)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no treatment
    E.8.2.4Number of treatment arms in the trial1
    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 concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the trial will be when 6 weeks has passed after the estimated due date of the last recruited participant who achieves a pregnancy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state200
    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)
    There is no follow-up or other intervention required after the end of the study. Participants cannot be re-randomised to the study after completing 3 cycles.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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