Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)

Infertility Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Placebo-controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702585
• Other study ID #: P07016
• Secondary ID: 38805
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2001
• Est. completion date: October 15, 2002

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 with WHO Group II anovulatory infertility. Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist. Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 15, 2002
• Est. primary completion date: October 15, 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Org 36286
Org 36286 single-dose subcutaneous injection
• Placebo
Placebo to Org 36286 as a single-dose subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Balen AH, Mulders AG, Fauser BC, Schoot BC, Renier MA, Devroey P, Struijs MJ, Mannaerts BM. Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with Wo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Ovulation Rate in Monofollicular Cycles		Up to 2 Weeks Following LH Peak
Secondary	Participant Overall Ovulation Rate		Up to 2 Weeks Following LH Pek
Secondary	Number of Participants With Cancellation of Menstrual Cycle		Up to Day 21
Secondary	Participant Follicle Size		Up to Day 21
Secondary	Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies		Up to 10 Weeks Following Ovulation
Secondary	Number of Participants Experiencing Serious Adverse Events (SAEs)		Up to 10 Weeks Following Ovulation
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		Up to 3 Weeks Following Ovulation
Secondary	Number of Participants With Clinically Significant Changes in Vital Signs		Up to 3 Weeks Followiing Ovulation
Secondary	Number of Participants With Antibodies to Org 36286		Up to 3 Weeks Following Ovulation
Secondary	Participant Serum Follicle Stimulating Hormone (FSH) Level		Up to Day 21
Secondary	Participant Serum LH Level		Up to Day 21
Secondary	Participant Inhibin-B, E2, and P Serum Concentration		Up to Day 21
Secondary	Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)		Up to 2 Weeks Following LH Peak