Parallel-Group Comparative Study of SJ-0021 and Purified Pituitary Gonadotropin in Subjects With Amenorrhea 1 or Anovulatory Cycles - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00467480

Purpose

To examine the efficacy of SJ-0021 versus purified pituitary gonadotropin for induction of ovulation and follicular development in subjects with amenorrhea I or anovulatory cycles, and to verify the non-inferiority of SJ-0021

Condition	Intervention	Phase
Infertility	Drug: SJ-0021 follitropin alpha [recombinant] Drug: Purified pituitary gonadotropin	Phase III

MedlinePlus related topics: Infertility

Drug Information available for: Sj-0021 Follicle Stimulating Hormone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	Parallel-Group Comparative Study of SJ-0021 and Purified Pituitary Gonadotropin in Subjects With Amenorrhea I or Anovulatory Cycles - Phase III Single-Blind Study

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Ovulation rate at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achieve a dominant follicular diameter of 18 mm in days hCG cancellation rate at 4 weeks Single follicular maturation rate at 4 weeks Pregnancy rate at 4 weeks Clinical pregnancy rate at 6 weeks [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	January 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SJ-0021 follitropin alpha [recombinant]	Drug: SJ-0021 follitropin alpha [recombinant] IMP is administered subcutaneously on consecutive days at a daily dose of 75 IU. If adequate follicular growth is not observed, increase the dose in an increment of 37.5 IU at intervals of 7 days. When the dominant follicle grows to 18mm in diameter, chorionic gonadotropin is administered once to induce ovulation.
2: Active Comparator Purified pituitary gonadotropin	Drug: Purified pituitary gonadotropin IMP is administered subcutaneously on consecutive days at a daily dose of 75 IU. If adequate follicular growth is not observed, increase the dose in an increment of 37.5 IU at intervals of 7 days. When the dominant follicle grows to 18mm in diameter, chorionic gonadotropin is administered once to induce ovulation.

Eligibility

Ages Eligible for Study:	20 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women aged 20 to 39 (inclusive) at the time of signing the informed consent form who hope to bear children
Subjects who have failed to achieve ovulation or pregnancy despite 2 cycles or more of anti-estrogen therapies (clomiphene citrate, cyclofenil, etc.). (To be included regardless of the time or medical institution at which anti- estrogen therapy was received.)
Subjects who exhibit withdrawal bleeding in a progesterone test (Includes spontaneous menstruation in subjects with anovulatory cycles.)
Subject having a body mass index (BMI: body weight (kg)/height (m)2) between 17.0 and 28.0 (decimals after the first decimal place are omitted) at the time of baseline test.
Subjects who voluntarily consent in writing to participate in the clinical trial

Exclusion Criteria:

with ovarian tumors
with ovarian enlargement not due to PCOS
having genitourinary hemorrhage of unknown cause
Subjects who are or may be pregnant, or who are lactating
having a history of allergic reaction or hypersensitivity to gonadotropin
with dysfunction of heart, lungs, liver, kidneys, or cardiovascular systems of Grade 2 or higher
with serum (Progesterone )P4 level ≥5ng/mL in baseline tests
with malignant tumors
with uterine amenorrhea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467480

Locations

Japan
Local Medical Information Office
Tokyo, Japan

Sponsors and Collaborators

EMD Serono

Investigators

Study Chair:

Kimitoshi Takemura

Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Additional Information:

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Development, R&D, Tokyo, Japan ( Merck Serono Co. Ltd. )
Study ID Numbers:	26648
Study First Received:	April 27, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00467480 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by EMD Serono:

Ovulation induction with Amenorrhea Type 1 or Annovulation

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Menstruation Disturbances
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Amenorrhea

Gonadotropins, Pituitary
Chorionic Gonadotropin
Genital Diseases, Male
Hormones
Follicle Stimulating Hormone

Additional relevant MeSH terms:

Infertility
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Amenorrhea
Reproductive Control Agents
Genital Diseases, Male
Hormones
Fertility Agents, Male
Pharmacologic Actions

Follicle Stimulating Hormone
Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Gonadotropins, Pituitary

ClinicalTrials.gov processed this record on May 07, 2009