Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women Wi… (NCT00702585) | Clinical Trial Compass
CompletedPhase 2
Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
55 participantsStarted 2001-08-01
Plain-language 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 infertility and to assess the safety (including the absence of antibody formation) of Org 36286.
Who can participate
Age range
18 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant Ovulation Rate in Monofollicular Cycles