Clinical trial
A Phase III, Uncontrolled Trial to Assess the Non-immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol
Name
P05714
Description
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.
Trial arms
Trial start
2006-09-26
Estimated PCD
2009-02-17
Trial end
2009-05-15
Status
Completed
Phase
Early phase I
Treatment
Corifollitropin alfa
Corifollitropin alfa 150 µg administered as a single subcutaneous dose.
Arms:
Corifollitropin alfa 150 µg
Other names:
Org 36286, SCH 900962, MK-8962
FSH
FSH administerd subcutaneously at a dose not to exceed 225 IU/day.
Arms:
Corifollitropin alfa 150 µg
GnRH antagonist
GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.
Arms:
Corifollitropin alfa 150 µg
(rec)hCG
(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.
Arms:
Corifollitropin alfa 150 µg
Progesterone
Progesterone administered vaginally at a dose of at least 600 mg/day.
Arms:
Corifollitropin alfa 150 µg
Size
682
Primary endpoint
Percentage of Participants With Clinically Relevant Immunogenicity
Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles
30 minutes post dose in each treatment cycle
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles
30 minutes post dose in each treatment cycle
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles
30 minutes post dose in each treatment cycle
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles
30 minutes post dose in each treatment cycle
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles
30 minutes post dose in each treatment cycle
Number of Participants With AEs
Up to approximately 26 months after first dose of corifollitropin alfa
Number of Participants With Serious AEs (SAEs)
Up to approximately 26 months after first dose of corifollitropin alfa
Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)
Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Eligibility criteria
Inclusion Criteria:
* Females of couples with an indication for COS and IVF or ICSI;
* \>=18 and \<=39 years of age at the time of signing informed consent;
* Body weight \> 60 kg and body mass index (BMI) \>=18 and \<=29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
* Willing and able to sign informed consent.
Exclusion Criteria:
* History of or any current (treated) endocrine abnormality;
* History of ovarian hyper-response or history of ovarian hyperstimulation syndrome (OHSS);
* History of or current polycystic ovary syndrome (PCOS);
* More than 20 basal antral follicles (size: \<11 mm, both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
* Less than 2 ovaries or any other ovarian abnormality, including endometrioma \>10 mm (visible on USS);
* Presence of unilateral or bilateral hydrosalpinx (visible on USS);
* More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/human menopausal gonadotrophin (hMG) treatment;
* FSH \> 12 IU/L or luteinizing hormone (LH) \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase, including abnormal cervical smear (Papanicolaou \[PAP\]\>=III, cervical intraepithelial neoplasia \[CIN\]\>=1);
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation);
* Recent history of or current epilepsy, human immunodeficiency virus (HIV) infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease;
* Abnormal karyotyping of the participant or her partner (if karyotyping is performed);
* History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of corifollitropin alfa;
* Use of hormonal preparations within 1 month prior to screening;
* Administration of investigational drugs within three months prior to signing informed consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 682, 'type': 'ACTUAL'}}
Updated at
2024-05-21
1 organization
5 products
1 indication
Organization
Organon and CoProduct
Corifollitropin alfaIndication
In Vitro FertilizationProduct
FSHProduct
GnRH antagonistProduct
(rec)hCGProduct
Progesterone