SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women

NCT01185782 | Completed Phase 3 Results DMC

• 1 other identifier: IMP26648
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.

Conditions

Infertility; Ovulation Induction

Keywords

Infertility; Ovulation induction; Gonalef® (Follitropin alfa); Purified pituitary gonadotropin (Fertinorm-P®); gonadotropin; Reproductive technologies, assisted; Polycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Ovulation

  Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.

  On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]

Secondary Outcomes (10)

• Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter

  Start of treatment period until Day 1 of post-treatment assessment period

• Time for Dominant Follicle to Achieve 18 mm in Mean Diameter

  Start of treatment period until Day 1 of post-treatment assessment period

• Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter

  Start of treatment period until Day 1 of post-treatment assessment period

• Human Chorionic Gonadotropin (hCG) Cancellation Rate

  Day 1 of post-treatment assessment period

• Single Follicle Maturation Rate

  Start of treatment period until Day 1 of post-treatment assessment period

Study Arms (2)

SJ-0021 group

EXPERIMENTAL

Drug: Gonalef® (Follitropin alfa)

Purified pituitary gonadotropin group

ACTIVE COMPARATOR

Drug: Purified pituitary gonadotropin (Fertinorm-P®)

Interventions

Gonalef® (Follitropin alfa) DRUG

Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.

Also known as: Gonalef®, follitropin alfa, recombinant human follicle-stimulating hormone, r-hFSH, SJ-0021

SJ-0021 group

Purified pituitary gonadotropin (Fertinorm-P®) DRUG

Subcutaneous administration of purified pituitary gonadotropin at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.

Also known as: Fertinorm-P®, purified urinary human follicle-stimulatin hormone, urofollitropin, u-hFSH

Purified pituitary gonadotropin group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20 to 39 years (inclusive) who hope to bear children
• Subjects who failed to achieve ovulation or pregnancy despite 2 cycles or more of anti-estrogen therapies (clomiphene citrate, cyclofenil, etc.)
• Subjects who exhibited withdrawal bleeding in a progesterone test (Includes spontaneous menstruation in subjects with anovulatory cycles.)
• Subjects having a body mass index between 17.0 and 28.0 at the time of baseline tests
• Subjects who voluntarily consented in writing to participate in the clinical trial

You may not qualify if:

• Subjects with ovarian tumors
• Subjects with ovarian enlargement not due to PCOS
• Subjects with genitourinary hemorrhage of unknown cause
• Subjects who were or may be pregnant, or who were lactating
• Subjects with history of allergic reaction or hypersensitivity to gonadotropin
• Subjects with dysfunction of heart, lungs, kidneys, or cardiovascular systems of Grade 2 or higher (in compliance with the Pharmaceutical and Medical Safety Bureau Notification Yakuan No. 80 \[issued 29 June 1992\])
• Subjects with serum progesterone (P4) level ≥ 5 ng/mL in baseline tests
• Subjects with malignant tumors
• Subjects with uterine amenorrhea
• Subjects with elevated levels of serum gonadotropin due to premature ovarian failure (FSH ≥ 20 mIU/mL)
• Subjects who were infertile due to known adrenal or thyroid dysfunction
• Subjects who were diagnosed as having hyperprolactinemia
• Subjects who had been documented or suspected of having intracranial lesions (e.g., pituitary tumors)
• Infertile subjects involving gynecological factors other than amenorrhea I or anovulatory cycles, and for whom ovulation induction therapy was found to be contraindicated
• Subjects who had participated in another clinical study within 6 months prior to start of the IMP administration

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., Japan: collaborator

Study Sites (1)

The University of Tokyo Hospital

Tokyo, Japan

Location

Related Publications (1)

• Taketani Y, Kelly E, Yoshimura Y, Hoshiai H, Irahara M, Mizunuma H, Saito H, Andoh K, Yanaihara T. Recombinant follicle-stimulating hormone (follitropin alfa) versus purified urinary follicle-stimulating hormone in a low-dose step-up regimen to induce ovulation in Japanese women with anti-estrogen-ineffective oligo- or anovulatory infertility: results of a single-blind Phase III study. Reprod Med Biol. 2010 Feb 23;9(2):99-106. doi: 10.1007/s12522-010-0046-5. eCollection 2010 Jun.

  PMID: 29699333 RESULT

MeSH Terms

Conditions

Infertility; Helping Behavior; Polycystic Ovary Syndrome

Interventions

follitropin alfa; Urofollitropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Menotropins; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono Co., Ltd., Japan, an affiliate of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Kimitoshi Takemura

  Merck Serono Co., Ltd., Japan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 20, 2010
• Study Start: February 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 27, 2013
• Results First Posted: February 24, 2012

Record last verified: 2013-12

Locations

JP (1)