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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702585
First received: June 18, 2008
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Org 36286
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Participant Ovulation Rate in Monofollicular Cycles [ Time Frame: Up to 2 Weeks Following LH Peak ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant Overall Ovulation Rate [ Time Frame: Up to 2 Weeks Following LH Pek ] [ Designated as safety issue: No ]
  • Number of Participants With Cancellation of Menstrual Cycle [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Participant Follicle Size [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies [ Time Frame: Up to 10 Weeks Following Ovulation ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 10 Weeks Following Ovulation ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 3 Weeks Following Ovulation ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Up to 3 Weeks Followiing Ovulation ] [ Designated as safety issue: Yes ]
  • Number of Participants With Antibodies to Org 36286 [ Time Frame: Up to 3 Weeks Following Ovulation ] [ Designated as safety issue: Yes ]
  • Participant Serum Follicle Stimulating Hormone (FSH) Level [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Participant Serum LH Level [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Participant Inhibin-B, E2, and P Serum Concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: Up to 2 Weeks Following LH Peak ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: August 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 36286 7.5 µg
Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Drug: Org 36286
Org 36286 single-dose subcutaneous injection
Other Name: Corifollitropin alpha
Experimental: Org 36286 15 µg
Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Drug: Org 36286
Org 36286 single-dose subcutaneous injection
Other Name: Corifollitropin alpha
Experimental: Org 36286 30 µg
Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Drug: Org 36286
Org 36286 single-dose subcutaneous injection
Other Name: Corifollitropin alpha
Experimental: Org 36286 60 µg
Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Drug: Org 36286
Org 36286 single-dose subcutaneous injection
Other Name: Corifollitropin alpha
Placebo Comparator: Placebo
Placebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Drug: Placebo
Placebo to Org 36286 as a single-dose subcutaneous injection

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702585     History of Changes
Other Study ID Numbers: P07016, 38805
Study First Received: June 18, 2008
Last Updated: June 24, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Ovulation Induction
Pharmacological effects of drugs
Hormones
Hormone substitutes and Hormone Antagonists
Pharmacological Actions
Randomized
Multi-center
Multi-national

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 29, 2014