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:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00697255
First received: June 11, 2008
Last updated: October 2, 2009
Last verified: October 2009
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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 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 Schering-Plough:
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 |
|---|---|
|
Experimental: Arm 1
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.
Other Name: Corifollitropin alfa
|
|
Experimental: Arm 2
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
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00697255 History of Changes |
| Other Study ID Numbers: | 107010, Eudract #: 2006-000705-30;, P05693 |
| Study First Received: | June 11, 2008 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Schering-Plough:
|
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 Chorionic Gonadotropin |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013