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A Phase 2 Trial to Evaluate if Org 36286 (Corifollitropin Alfa), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (Study 107010)
This study has been terminated.
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00697255
  Purpose

The primary objective of this trial is to evaluate whether an Org 36286 regimen applying a single or repeated dose of Org 36286 followed by a low daily dose of hCG or recFSH can induce monofollicular growth (one follicle >= 18 mm and no other follicle >= 15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.


Condition Intervention Phase
Ovulation Induction
 Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG
Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH
 Phase II

MedlinePlus related topics: Infertility
Drug Information available for: Corifollitropin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Randomized, Controlled, Open-Label, Feasibility Trial to Evaluate if a Single or Repeated Dose of Org 36286 (Corifollitropin Alfa) Followed by a Low Daily Dose of Either hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility

Further study details as provided by Organon:

Primary Outcome Measures:
  • The primary endpoint for the study is the monofollicular growth rate (one follicle >= 18 mm and no other follicle >= 15 mm) at day of bolus injection of hCG. [ Time Frame: At day of bolus injection of hCG, maximal at day 20. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovulation rate (total and monofollicular); Cancellation rate/ Reasons for cancellation; Number and size of follicles; Serum FSH, LH, E2, Inhibin-B and Progesterone levels; Pregnancy [ Time Frame: During stimulation period (from first Org 36286 injection to bolus injection of hCG) ] [ Designated as safety issue: No ]
  • Safety (including OHSS) [ Time Frame: During stimulation period (from first Org 36286 injection to bolus injection of hCG) ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: August 2006
Estimated Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental
Org 36286 and 200 IU hCG
Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG
Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ia:15 ug, stage Ib/II: 30 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ia: 15 ug, stage Ib/II: 20 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with hCG (stage Ib/II: 200 IU)/ FSH (stage Ia: 50 IU, stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.
Arm 2: Experimental
Org 36286 and 50IU/75IU recFSH
Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH
Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ia:15 ug, stage Ib/II: 30 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ia: 15 ug, stage Ib/II: 20 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with hCG (stage Ib/II: 200 IU)/ FSH (stage Ia: 50 IU, stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.

Detailed Description:

This trial will include two separate stages (Ia+Ib and II).

Stage Ia is open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of Org 36286 followed by daily low dose recFSH provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.

Stage Ib is open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of Org 36286 followed by daily low dose hCG provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.

Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of Org 36286 followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.

  Eligibility

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

Inclusion Criteria:

  • Oligomenorrhea (average cycle length >= 35 days and < 6 months);
  • BMI >= 18 and <= 30 kg/m^2;
  • Normal serum FSH levels and normal E2 levels at screening;
  • Progestagen induced withdrawal bleeding;
  • Age >= 18 and <= 39 years at the time of signing informed consent;
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • 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 Org 36286;
  • Hypersensitivity to hCG/ Puregon® or any of its components;
  • Previous use of Org 36286;
  • Use of any investigational drug during 90 days before screening.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 107010, Eudract number: 2006-000705-30
Study First Received: June 11, 2008
Last Updated: June 18, 2008
ClinicalTrials.gov Identifier: NCT00697255  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Organon:
Pharmacological effects of drugs
Hormones
Hormone Substitutes and Hormone Antagonists
Pharmacological Actions
 Monofollicular growth
Randomized
Open-label
Active-controlled

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 15, 2009



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