Status:
COMPLETED
Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
Brief Summary
The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory ...
Detailed Description
This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women...
Eligibility Criteria
Inclusion
- Wish to conceive;
- Oligomenorrhea (cycle length \>=41 days) or amenorrhea (no menstrual cycle for \>6 months);
- Body Mass Index (BMI) \>=18 and \<=32 kg/m\^2;
- Serum FSH levels within normal limits (1-10 IU/L);
- Normal serum prolactin and thyroid stimulating hormone (TSH) levels;
- Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding;
Exclusion
- Tumours of the ovary, breast, uterus, pituitary or hypothalamus;
- Pregnancy or lactation;
- Undiagnosed vaginal bleeding;
- Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);
- Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
- Malformations of the sexual organs incompatible with pregnancy;
- Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation);
- Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment;
- Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment;
- Alcohol or drug abuse within the 12 months preceding signing of informed consent;
- Any clinically relevant abnormal laboratory value;
- Hypersensitivity to any of the substances in Org 36286;
- Hypersensitivity to Orgalutran® or any of its components;
- Use of any investigational drugs during 90 days before screening or previous participation in this trial.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2002
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00702585
Start Date
August 1 2001
End Date
October 15 2002
Last Update
August 15 2024
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