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Open-label, Parallel-group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 μg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary 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


Phase 3
20 Years
39 Years
Open (Enrolling)
Female
Anovulation, Oligo-ovulation, Hypothalamic-pituitary Dysfunction, Polycystic Ovarian Syndrome

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Trial Information

Open-label, Parallel-group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 μg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary 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


Inclusion Criteria:



- Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive.

- BMI of 17.0 to 29.0 kg/m2 inclusive (value up to first decimal place).

- No clinically significant abnormalities in serum TSH, DHEA-S, 17-OHP, PRL and 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 WHO standards, within 12
months prior to date of informed consent.

- Normal cervical smear results (PAP score ≤ 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 PCOS, and for whom 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).

- Untreated endometrial hyperplasia.

- Abnormal hemorrhage of the reproductive tract of unknown origin.

- History of severe ovarian hyperstimulation syndrome (OHSS) (Classification of OHSS
Severity, Japan Reproductive/Endocrine Working Group).

- Clinically significant systemic disease (e.g. insulin-dependent diabetes, epilepsy,
severe migraine, intermittent porphyria, hepatic, renal or cardiovascular disease,
severe corticosteroid-dependent asthma).

- Participation in another clinical trial within 3 months prior to date of informed
consent or simultaneous participation in another clinical trial.

- Gonadotropin treatment within 2 months prior to date of informed consent.

- Legal incapacity or limited legal capacity.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Title: Percentage of Participants Who Ovulated, defined as mid-luteal serum progesterone levels of >= 5 ng/mL or a clinical pregnancy

Outcome Description:

Mid-luteal serum progesterone values will reflect the higher of the values taken during the visit on day 5-7 and the visit on day 8-10. However, if clinical pregnancy is achieved, then this will be counted as successful ovulation regardless of the mid-luteal serum progesterone levels.

Outcome Time Frame:

up to study day 10

Safety Issue:

No

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR701173_002

NCT ID:

NCT01653743

Start Date:

September 2012

Completion Date:

August 2013

Related Keywords:

  • Anovulation
  • Oligo-ovulation
  • Hypothalamic-pituitary Dysfunction
  • Polycystic Ovarian Syndrome
  • Japanese
  • Anovulation
  • Polycystic Ovary Syndrome

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