oligoanovulatory infertile women who are candidates for ovulation induction (OI) MedDRA version: 9.1 Level: PT Classification code 10033312 Term: Ovulation induction
Conditions
Interventions
Product Name: AS900672-Enriched
Pharmaceutical Form: Powder for injection*
Trade Name: GONAL-f
Pharmaceutical Form: Solution for injection
Sponsors
Merck Serono International S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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 within the prior 6 months or response to clomiphene citrate evidenced by ovulation 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. No clinically significant abnormalities in serum TSH, DHEA-S, prolactin, and FSH levels in the early follicular phase, 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. Subjects receiving stable dose of dopamine agonists can be enrolled at the discretion of the investigator if local laboratory results demonstrate adequate control of prolactin levels, 6. No clinically significant abnormalities in fasting glucose and fasting insulin levels, 7. Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of hysterosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years, 8. PAP smear test without clinically significant abnormalities within 6 months prior to the first screening procedure. If PAP smear was not done, it must be performed as part of screening procedures, 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 the first screening procedure. If semen analysis was not done, it must be performed as part of screening procedures, Note: Use of donor or frozen sperm is not allowed. 11.Willing and able to comply with all protocol procedures, including pregnancy, and neonatal follow-upl, 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 or requiring treatment, 13. Ovarian cyst with a mean diameter of >25 mm on the day of randomisation, 14. History or suspicion of ovarian, uterine or mammary cancer, 15. Adrenal congenital hyperplasia, partial or complete enzymatic block, 16. Use of metformin ror other insulin sensitising agents 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 or suspected infection with human immunodeficiency virus (HIV), Hepatitis B or C 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 investigational drug 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 concurrent disease (including diabetes mellitus and autoimmune diseases) that would compromise subject safety or interfere with the study assessments or clinically significant abnormal laboratory finding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective: Identify the optimal dose of AS900672- Enriched to induce ovulation in oligo-anovulatory infertile women.;Secondary Objective: Secondary objectives: Demonstrate that the clinical pregnancy rate of the optimal dose of AS900672-Enriched is within the range of the clinical pregnancy rate obtained with follitropin alfa daily dosing, and Evaluate safety and tolerability of AS900672-Enriched in oligo-anovulatory infertile women undergoing OI. Other objectives: Further evaluate the pharmacokinetics and pharmacodynamics of AS900672-Enriched.;Primary end point(s): Primary endpoint is the ovulation rate. | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed