Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

Merck KGaA, Darmstadt, Germany6 sites in 1 country81 target enrollmentSeptember 2012

ConditionsAnovulation Oligo-ovulation Hypothalamic-pituitary Dysfunction Polycystic Ovarian Syndrome

InterventionsMSJ-0011 Follitropin alpha urinary hCG (u-hCG)

DrugsMSJ-0011 urinary hCG (u-hCG)Follitropin alpha

Overview

Phase: Phase 3
Intervention: MSJ-0011
Conditions: Anovulation
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 81
Locations: 6
Primary Endpoint: Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive
•Body Mass Index (BMI) of 17.0 to 29.0 kilogram per square meter (kg/m\^2) inclusive (value up to first decimal place)
•No clinically significant abnormalities in serum thyroid stimulating hormone (TSH), dehydroepiandrosterone sulfate (DHEA-S), 17-hydroxyProgesterone (17-OHP), prolactin (PRL) and follicle-stimulating hormone (FSH) levels in the early follicular phase
•Anovulation or oligo-ovulation
•Any one of the following: spontaneous menstruation (at least twice per year) or a positive response to progestin as evidenced by menstruation.
•Eligible for ovarian stimulation with gonadotropins (e.g. documented failure to ovulate or achieve pregnancy with anti-estrogenic therapy such as clomiphene citrate)
•Male partner with normal semen analysis, as defined by World Health Organization (WHO) standards, within 12 months prior to date of informed consent
•Normal cervical smear results (Papanicolaou \[PAP\] score less than or equal to \[\<=\] II) taken within 12 months prior to date of informed consent; if not available a cervical smear will be performed as part of screening
•Full comprehension of the trial and voluntary consent obtained in writing prior to participation in this trial

Exclusion Criteria

•Infertility involving gynecological factors other than anovulation or oligo-ovulation secondary to hypothalamic-pituitary dysfunction (Grade 1 Amenorrhea, Oligomenorrhea or Anovulatory Cycles) or polycystic ovarian syndrome (PCOS) and for whom ovulation induction (OI) therapy is contraindicated
•Subjects with known surgical/histological diagnosis of endometriosis greater than Stage II (American Fertility Society classification), or endometriosis requiring treatment
•Infertility secondary to amenorrhea of uterine cause
•Infertility secondary to primary or premature ovarian failure
•Infertility secondary to known adrenal or thyroid dysfunction, or hyperprolactinemia
•Failure of ovulation in 2 or more consecutive previous cycles with any gonadotropins
•Subjects in whom pregnancy is contraindicated, e.g. malformations of sexual organs or fibroid tumors of the uterus incompatible with pregnancy
•Extrauterine pregnancy in the previous 3 months
•History or presence of intracranial tumor (e.g. hypothalamic or pituitary tumor)
•Presence of or suspected gonadotropin- or estrogen-dependent malignancy (e.g. ovarian, uterine or mammary carcinoma)

Arms & Interventions

MSJ-0011

Intervention: MSJ-0011

MSJ-0011

Intervention: Follitropin alpha

urinary hCG

Intervention: urinary hCG (u-hCG)

urinary hCG

Intervention: Follitropin alpha

Outcomes

Primary Outcomes

Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy

Time Frame: Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment

Ovulation was defined as mid-luteal serum progesterone level of \>= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).

Secondary Outcomes

Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy(Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment)
Mid-luteal Endometrial Thickness(Day 5 to 7 post hCG treatment)
Percentage of Participants With Biochemical Pregnancy(Day 35 to 42 post hCG treatment)
Percentage of Participants With Clinical Pregnancy(Day 35 to 42 post hCG treatment)