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)(TERMINATED)(P05693)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00697255
First received: June 11, 2008
Last updated: August 29, 2013
Last verified: August 2013
  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 + 200 IU hCG
Drug: Org 36286 + recFSH 50IU/75IU
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 326826 + hCG 200 IU
Eligible participants 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 participant 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 participant will start daily injections with hCG (Stage Ib/II: 200 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.
Drug: Org 36286 + 200 IU hCG
Subcutaneous Org 36286 + hCG 200 IU
Other Name: Corifollitropin alfa
Experimental: Org 366286 + recFSH 50IU/75IU
Eligible participants will receive a subcutaneous injection of Org 36286 (Stage 1a: 15ug, 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 participant will receive a second or third dose of Org 36282 (Stage 1a: 15 ug, Stage Ib/II: 20 ug). As soon as the largest follicle reaches a size of >= 12 mm, the participant will start daily injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at lease one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.
Drug: Org 36286 + recFSH 50IU/75IU
Subcutaneous Org 36286 + recFSH 50IU/75IU
Other Name: Corifollitropin alfa

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 participants 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 participants 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 participants 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);
  • Amenorrhea (average cycle length >= 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 years 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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00697255     History of Changes
Other Study ID Numbers: P05693, EudraCT #: 2006-000705-30, 107010
Study First Received: June 11, 2008
Last Updated: August 29, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Merck Sharp & Dohme Corp.:
Pharmacological effects of drugs
Hormones
Hormone Substitutes and Hormone Antagonists
Pharmacological Actions
Monofollicular growth
Randomized
Open-label
Active-controlled

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

ClinicalTrials.gov processed this record on April 22, 2014