Status:
TERMINATED
A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)
Lead Sponsor:
Organon and Co
Conditions:
Ovulation Induction
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
Brief Summary
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human C...
Detailed Description
This trial will include two separate stages (Ia+Ib and II). Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitr...
Eligibility Criteria
Inclusion
- Oligomenorrhea (average cycle length ≥35 days and \<6 months)
- Amenorrhea (average cycle length ≥6 months)
- Body Mass Index ≥18 and ≤30 kg/m\^2
- Normal serum FSH levels and normal estradiol levels at screening
- Progestagen induced withdrawal bleeding
- Age ≥18 years and ≤39 years at the time of signing informed consent
- Willing and able to sign informed consent
Exclusion
- History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS)
- History of or current tumors of the ovary, breast, uterus, pituitary or
- hypothalamus
- Less than 2 ovaries
- Undiagnosed vaginal bleeding
- Any ovarian and/or abdominal abnormality interfering with ultrasound
- examination
- Malformations of the sexual organs incompatible with pregnancy
- Pregnancy or lactation
- Abnormal serum endocrinology levels based on screening sample
- Any clinically relevant abnormal laboratory value based on screening sample
- Alcohol or drug abuse within the 12 months preceding signing of informed consent
- Hypersensitivity to any of the substances in corifollitropin alfa
- Hypersensitivity to hCG/ Puregon® or any of its components
- Previous use of corifollitropin alfa
- Use of any investigational drug during 90 days before screening
Key Trial Info
Start Date :
May 15 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00697255
Start Date
May 15 2007
End Date
May 15 2008
Last Update
June 17 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.