E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017399 |
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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 assess the non-immunogenicity and safety of Org 36286 in patients undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI; 2. ≥18 and ≤ 39 years of age at the time of signing informed consent; 3. Body weight > 60 kg and BMI ≥ 18 and ≤ 29 kg/m2; 4. Normal menstrual cycle length: 24-35 days; 5. Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed); 6. Willing and able to sign informed consent. |
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E.4 | Principal exclusion criteria |
1. History of or any current (treated) endocrine abnormality; 2. History of ovarian hyper-response or history of ovarian hyperstimulation syndrome (OHSS); 3. History of or current polycystic ovary syndrome (PCOS); 4. More than 20 basal antral follicles (size: <11 mm, both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5); 5. Less than 2 ovaries or any other ovarian abnormality including endometrioma >10 mm (visible on USS); 6. Presence of unilateral or bilateral hydrosalpinx (visible on USS); 7. More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable); 8. History of non- or low ovarian response to FSH/hMG treatment; 9. FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); 10. Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase; (including abnormal cervical smear (PAP ≥III, CIN ≥1)); 11. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation); 12. Recent history of or current epilepsy, HIV infection, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease; 13. Abnormal karyotyping of the patient or her partner (if karyotyping is performed); 14. History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; 15. Previous use of Org 36286; 16. Use of hormonal preparations within 1 month prior to screening; 17. Administration of investigational drugs within three months prior to signing informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Non-immunogenicity and safety of Org 36286 |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
antibody formation (non-immunogenicity) |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 11 |