Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Co., Ltd., Japan
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01653743
First received: July 20, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 μg subcutaneous dose of MSJ-0011 to a single 5,000 IU intramuscular dose of urinary 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.


Condition Intervention Phase
Anovulation
Oligo-ovulation
Hypothalamic-pituitary Dysfunction
Polycystic Ovarian Syndrome
Drug: MSJ-0011
Drug: urinary hCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Title: Percentage of Participants Who Ovulated, defined as mid-luteal serum progesterone levels of >= 5 ng/mL or a clinical pregnancy [ Time Frame: up to study day 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Title: Percentage of Participants Who Ovulated, defined as mid-luteal serum progesterone levels of >= 9.4 ng/mL or a clinical pregnancy [ Time Frame: up to study day 10 ] [ Designated as safety issue: No ]
    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.

  • Mid-luteal Endometrial Thickness [ Time Frame: study days 5-7 ] [ Designated as safety issue: No ]
    Endometrial thickness will be measured using transvaginal ultrasound

  • Percentage of Participants Who Had a Biochemical Pregnancy [ Time Frame: study days 15-20 ] [ Designated as safety issue: No ]
    Biochemical pregnancy is defined as a positive result to the serum β-hCG pregnancy

  • Percentage of Participants Who Had a Clinical Pregnancy [ Time Frame: study days 35-42 ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSJ-0011 Drug: MSJ-0011
MSJ-0011, single 250 μg subcutaneous dose, presented in a prefilled syringe
Active Comparator: urinary hCG Drug: urinary hCG
Urinary hCG, single 5,000 IU intramuscular dose (freeze-dried formulation)

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653743

Contacts
Contact: Yukito Kuwahara, Clinical Trial Leader +81-3-6853-8511 yukito.kuwahara@merckgroup.com

Locations
Japan
Hanabusa Women's Central Fertility Clinic Recruiting
Hyogo, Japan
Bashamichi Ladies Clinic Recruiting
Kanagawa, Japan
Sophia Ladies Clinic Recruiting
Kanagawa, Japan
Ivf Namba Clinic Recruiting
Osaka, Japan
Ivf Osaka Clinic Recruiting
Osaka, Japan
Department of Obstetrics and Gynecology, Saitama Medical University Hospital Recruiting
Saitama, Japan
Sponsors and Collaborators
Merck KGaA
Merck Serono Co., Ltd., Japan
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01653743     History of Changes
Other Study ID Numbers: EMR701173_002
Study First Received: July 20, 2012
Last Updated: June 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck KGaA:
Japanese

Additional relevant MeSH terms:
Anovulation
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014