An observational study in Anovulation, sponsored by Organon and Co. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Organon and Co · Observational
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's enrollment of 384 is above the median of 300 across 17 observational studies indexed under Anovulation.
Browse Anovulation studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Japanese 300 patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction
Drug: Follitropin beta
For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.
Occurrence of ovulation
Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.
Pregnancy outcome
Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.
No study locations are listed for this record.
The record gives a start of Jul 2007, a primary completion of Mar 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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