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    Summary
    EudraCT Number:2012-003227-38
    Sponsor's Protocol Code Number:EMR700623_535
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2012-003227-38
    A.3Full title of the trial
    A Multi-Centre, Two-Arm, Interventional, Phase IV Study to Evaluate Tailoring of Recombinant FSH Treatment in Subjects with Chronic Anovulation Using the Gonal-f® Prefilled Pen in Women Undergoing Ovulation Induction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess two treatment regimes of injectable hormones, Gonadotrophins, which are used to treat fertility problems in women, in the effectiveness of inducing egg stimulation in women who are unable to ovulate by themselves.
    A.3.2Name or abbreviated title of the trial where available
    Low Dose Gonal-f in Ovulation Induction (LoGo)
    A.4.1Sponsor's protocol code numberEMR700623_535
    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 SponsorMerck Serono Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportMerck Serono Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Serono Ltd
    B.5.2Functional name of contact pointRichard Coles
    B.5.3 Address:
    B.5.3.1Street AddressBedfont Cross, Stanwell Road
    B.5.3.2Town/ cityFeltham, Middlesex
    B.5.3.3Post codeTW14 8NX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02088187204
    B.5.6E-mailrichard.coles@merckgroup.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 Yes
    D.2.1.1.1Trade name GONAL-f
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGONAL-f
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 450 to 900
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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
    Anovulation in women with PCOS
    E.1.1.1Medical condition in easily understood language
    Women who fail to release an egg monthly
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033312
    E.1.2Term Ovulation induction
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    The primary research question in this study is whether a low dose FSH treatment method, with smaller dose increase increments, can be considered ‘non-inferior’ to (i.e. not worse than) an established low-dose FSH treatment when trying to achieve adequate growth of just one follicle (containing an egg) in anovulatory women.
    E.2.2Secondary objectives of the trial
    To investigate the number of treatment cycles that result in the growth of two follicles.

    To investigate the number of treatment cycles that result in the growth of more than two follicles

    To investigate the number of treatment cycles that result in ovulation (after hCG).

    To report the number of cycles where hCG was not given
    -due to inadequate follicle growth after 5 weeks of rFSH stimulation.
    -due to excessive follicle growth.

    To report the number of cycles resulting in a pregnancy
    - positive pregnancy test
    - clinical pregnancy confirmed by ultrasound scan

    To report the number of multiple pregnancies

    To report the number miscarriages after confirmation of clinical pregnancy (by ultrasound scan)

    To report the number of cycles with an adverse event
    - Ovarian Hyper Stimulation Syndrome.
    - local tolerability (injection site reactions).
    - other.

    To report the average duration of Gonal-f treatment in each cycle.

    To report the average total dose of Gonal-f
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects eligible for ovulation induction treatment, where monofollicular development is the desired treatment outcome and the dose schedule outlined in the protocol is deemed appropriate
    2. Premenopausal female subjects, aged between 18 and 37 years inclusive
    3. Subjects desirous of pregnancy / willing to conceive
    4. Subjects who are infertile due to chronic anovulation demonstrated by a cycle duration of > 35 days.
    5. Subjects who have been treated with clomifene citrate therapy, according to standard site practice, and have failed to ovulate and/or conceive
    6. Subjects with FSH and PRL serum values within the normal range in the early follicular phase
    7. Subjects with an overall total antral follicle count > 10 (of follicle size ≥ 2 mm and < 11 mm) (i.e. total between both ovaries)
    8. Subjects with at least one patent tube, as documented by recent (within 2 years before treatment assignment) hysterosalpingography (HSG) or hysterosalpingo contrast sonography (HyCoSy)
    9. Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG or ultrasound scan
    10. Subjects with body mass index (BMI) >20 and ≤32 kg/m2
    11. Subjects with negative cervical Papanicolaou (PAP) test conducted according to national guidelines and/or standard site practice.
    12. Male partners of female subjects with sperm compatible with non-assisted fertilization or availablility of donor sperm, as confirmed by the Investigator.
    13. Subjects who are willing and able to comply with protocol requirements and have provided written, informed consent
    E.4Principal exclusion criteria
    1. Subjects with history of hypersensitivity to the IMP (active substance follitropin alpha, FSH, or to any of the excipients of Gonal-f) or any other drug used in the trial (i.e. Ovitrelle)
    2. Subjects with ovarian enlargement or ovarian cyst unrelated to PCOS, and of unknown origin on ultrasound
    3. Subjects with evidence of diminished ovarian reserve (cycle length < 26 days; FSH above the upper limit of local serum FSH values, total antral follicle count (AFC) in both ovaries < 10)
    4. Subjects with uterine pathology/abnormalities, which in the opinion of the investigator could impair pregnancy evolution
    5. Subjects who have undergone three or more previous miscarriages
    6. Subjects with any previous extrauterine pregnancy
    7. Pregnant or lactating female subjects
    8. Subjects with abnormal gynaecological bleeding of unknown aetiology.
    9. Subjects with previous history of severe OHSS (after clomifene treatment)
    10. Subjects who have evidence of current or previous pelvic inflammatory disease before treatment assignment
    11. Subjects with tumours of the hypothalamus and pituitary gland
    12. Subjects with ovarian, uterine or mammary carcinoma
    13. Subjects treated with clomifene citrate or gonadotropins within 1 month of the screening evaluation
    14. Subjects with any medical condition which, in the opinion of the investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy
    15. Subjects with any medical condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug
    16. Subjects with any clinically significant systemic disease (e.g. insulin-dependent diabetes) or any contraindication to being pregnant and/or carrying a pregnancy to term
    17. An active substance abuser
    18. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
    19. Subjects who are currently participating in another clinical trial
    20. Subjects who are unable to give written informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of cycles with monofollicular development (defined as only one follicle >17mm and no other follicles > 14mm following up to 4 weeks Gonal-f treatment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following completion of treatment with Gonal-f (up to 4 weeks). Ultrasound scan at final adhoc clinic visit.
    E.5.2Secondary end point(s)
    • Proportion of cycles with bifollicular development (defined as only two follicle >17mm following up to 4 weeks Gonal-f treatment).
    • Proportion of cycles with multifollicular development (defined as three or more follicles >14mm following up to 4 weeks Gonal-f treatment).
    • Proportion of ovulatory cycles (after hCG).
    • Proportion of cycles where hCG was not given
    o due to inadequate follicle development after 4 weeks of rFSH.
    o due to excessive response.
    • Proportion of cycles resulting in a pregnancy
    o positive pregnancy test.
    o clinical pregnancy (at least one foetal sac on ultrasound 35 to 42 days after hCG).
    • Number and incidence of multiple pregnancy (and number of foetuses).
    • Number and incidence of miscarriages after confirmation of clinical pregnancy
    • Number and proportion of cycles with an adverse event
    o OHSS (and grade).
    o local tolerability.
    o other.
    • Duration of rFSH stimulation (days) prior to hCG.
    • Total dose (IU) of rFSH administered per cycle.
    • AMH level reported at Baseline and last visit pre-hCG, and difference in AMH levels between these visits.
    • Testosterone levels at baseline reported with outcome of OI cycle.
    • SHBG levels at baseline reported with outcome of OI cycle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follicular development will be assessed following a maximum of 4 weeks treatment with Gonal-f.

    All other endpoints will be assessed following confirmation of clinical pregnancy.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Gonal-f at different dose increments
    E.8.2.4Number of treatment arms in the trial2
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    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
    Database lock
    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 months6
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 94
    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 state94
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 94
    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)
    Subjects who become pregnant in the trial will be followed up until birth (or otherwise) and should not require any further treatment. For subjects who do not become pregnant in the trial, further treatment/intervention will be at the discretion of the treating physician.
    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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-23
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