E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
oligoanovulatory infertile women who are candiates for ovulation indujction (OI) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033312 |
E.1.2 | Term | Ovulation induction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
TO IDENTIFY THE OPTIMAL EFFECTIVE DOSE OF AS900672-ENRICHED TO INDUCE OVULATION IN OLIGO-ANOVULATORY INFERTILE WOMEN |
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E.2.2 | Secondary objectives of the trial |
TO DEMONSTRATE THAT THE CLINICAL PREGNANCY RATE OF THE OPTIMAL EFFECTIVE DOSE OF AS900672-ENRICHED IS WITHIN THE RANGE OF THE CLINICAL PREGANANCY RATE OBTAINED WITH FOLLITROPIN ALFA DAILY DOSING AND TO EVALUATE SAFETY AND TOLERABILITY OF AS900672-ENRICHED IN OLIGO-ANOVULATORY INFERTILE WOMEN UNDERGOING OI |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Oligo-anovulation defined by a menstrual period duration of 35 days to 6 months, 2. Spontaneous menses or a positive response to progestin or clomiphene citrate withdrawal within the prior 6 months, 3. Aged between 18 and 36 years, inclusive, at time of informed consent signature, 4. Body mass index 18 to 30 kg/m2, inclusive, 5. Early follicular phase serum TSH, DHEA-S, prolactin, and FSH within the normal range for the central laboratory,Exception: Subjects with low TSH level who receive replacement therapy can be enrolled at the discretion of the investigator if local laboratory results (T4) demonstrate satisfactory thyroid function, 6. Fasting glucose and fasting insulin within the normal range for the central laboratory, 7. Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of HSG and/or laparoscopy-hysteroscopy within the prior 3 years, 8. PAP smear test without clinically significant abnormalities within 6 months prior to randomisation, 9. Negative pregnancy test prior to randomisation, 10. Male partner with semen analysis demonstrating adequacy for Insemination via intercourse and/or IUI within 6 months prior to randomisation,Note: Use of donor sperm is not allowed, 11. Willing and able to comply with the protocol, and 12.Voluntary provision of written informed consent, prior to any trial-related procedure that was not part of normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial. |
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E.4 | Principal exclusion criteria |
1. History of ≥ 2 consecutive gonadotrophin stimulation cycles that did not lead to ovulation, 2. History of clomiphene citrate stimulation cycles of which none led to ovulation, 3. Prior excessive response to gonadotrophin stimulation, defined as the development of ≥4 mature follicles (>17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of ≤ 75 IU/day, 4. Previous severe ovarian hyperstimulation syndrome (OHSS), 5. Administration of any gonadotrophin, clomiphene citrate, GnRH analogue, tamoxifen or aromatase inhibitors within the prior 30 days, 6. Laparoscopic ovarian drilling and/or ovarian cauterisation within the prior 6 months, 7. Any contraindication to pregnancy and/or to carrying pregnancy to term, 8. A clinical pregnancy that ended in a miscarriage within the prior 3 months, 9. History of ≥ 3 consecutive miscarriages, due to any cause, 10. Abnormal gynaecological bleeding of undetermined origin, 11. Clinically significant abnormal findings of the uterine cavity evident on a transvaginal pelvic ultrasound performed during screening, 12. Presence of endometriosis grade III IV, 13. Ovarian cyst with a mean diameter of >25 mm and E2 > 80 pg/mL on the day of randomisation, 14. History of ovarian, uterine or mammary cancer, 15. Adrenal congenital hyperplasia, partial or complete enzymatic block, 16. Use of metformin related to infertility within the prior 2 months, 17. Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial, 18. Any contra-indication to gonadotrophin therapy, 19. Known infection with human immunodeficiency virus (HIV), or positive hepatitis B surface antigen (HBsAg) or anti-hepatitis C antibodies in the trial subject or her male partner, 20. Any active substance abuse or history of drug, medication or alcohol abuse within the prior 5 years, 21. Smoker consuming more than 5 cigarettes per day, 22. Serum testosterone (central laboratory) that is suggestive of ovarian tumour, 23. Previously randomised in this trial or participation in another clinical trial within the prior 3 months, 24. Any medical condition, which in the judgment of the Investigator may interfere with the absorption, distribution, metabolism or excretion of r-hFSH, or 25. Clinically significant systemic disease, including diabetes mellitus, or clinically significant abnormal laboratory finding. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |