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Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females (Compass)

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ClinicalTrials.gov Identifier: NCT01923194
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females

Condition or disease Intervention/treatment Phase
Anovulation Drug: Highly Purified Urofollitropin Drug: Recombinant Human Follitropin Alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate
Study Start Date : October 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Group Drug: Highly Purified Urofollitropin
for Injection
Other Name: Bravelle®

Active Comparator: Comparator Group Drug: Recombinant Human Follitropin Alfa
for Injection
Other Name: Gonal-F®




Primary Outcome Measures :
  1. The ovulation rate defined as the percentage of subjects who present ovulation [ Time Frame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration ]

Secondary Outcome Measures :
  1. The positive serum progesterone rate [ Time Frame: 6~9 days post hCG administration ]
  2. The positive serum β-hCG/hCG rate [ Time Frame: 18~22 days post hCG administration ]
  3. The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]
    Regardless of fetal heart beat

  4. The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]
    With fetal heart beat

  5. The ongoing pregnancy rate [ Time Frame: 11~12 weeks post hCG administration ]
  6. The follicular development [ Time Frame: On the day of hCG administration ]
  7. Endometrial thickness [ Time Frame: On the day of hCG administration ]
  8. Total FSH (Follicle-stimulating hormone) dose administered [ Time Frame: On the day of hCG administration ]
  9. Number of FSH treatment days [ Time Frame: On the day of hCG administration ]
  10. Frequency and severity of adverse events [ Time Frame: Expected maximum of 6 months ]
  11. Frequency and severity of injection site reactions [ Time Frame: Day 1 up to Day 28 of the ovarian stimulation period ]
  12. Serum estradiol (E2) levels [ Time Frame: On the day of hCG administration ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form prior to screening evaluations
  • Chinese females between the ages of 20-39 years
  • Infertility for at least 1 year before screening
  • Women WHO type II anovulatory infertility with chronic anovulation (defined as amenorrhoea (i.e., no menstrual bleeding for 6 months or more) or oligoamenorrhoea (i.e., cycles of more than 35 days) ) with progestogen induced withdrawal bleeding or spontaneous menstrual bleeding
  • Failure to conceive after at least one cycle of ovulation induction with clomiphene citrate
  • Bilateral tubal patency documented by a hysterosalpingography or sonohysterography or laparoscopy within 2 years prior to screening
  • Normal pelvis documented by a transvaginal ultrasound with respect to uterus, Fallopian tubes and ovaries within 3 months prior to screening
  • Early follicular phase serum levels of FSH within normal limits (1-12 IU/L,) (results obtained within 2 months prior to randomization)
  • LH (Luteinizing hormone), prolactin , E2 (estradiol), progesteron, total testosterone, and TSH (thyrotropin) levels within normal limits for the clinical laboratory
  • Male partner with a semen analysis obtained within 12 months prior to randomisation and showing acceptable values for semen according to the local laboratory, or showing more than 2.000.000 progressive motile sperm per mL after capacitation (in case of IUI (intrauterine insemination))
  • BMI (Body mass index) is ≥ 18.5 and < 30 kg/m2

Exclusion Criteria:

  • Any known clinically significant systemic disease
  • Known past or current thrombophlebitis or thromboembolism including venous thrombosis disease and active or recent arterial thrombosis disease
  • Any known endocrine or metabolic abnormalities which can compromise participation in the trial with the exception of controlled thyroid function disease
  • Any known concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), anti-psychotics, anxiolytics, hypnotics and sedatives, and need for continuous use of prostaglandin inhibitors (non-steroid anti- inflammatory drugs (NSAIDs), including aspirin) at the time of study entry.
  • Known history of 12 or more unsuccessful (no pregnancy achieved) ovulation induction cycles
  • Any known treatment with clomiphene citrate, metformin, gonadotropins or GnRH analogues within one month prior to randomisation
  • Ovarian cysts with a mean diameter ≥ 15 mm that have persisted for more than one cycle or ovarian endometrioma on ultrasound
  • Known at least one previous cycle experienced luteinized unruptured follicle syndrome
  • Known abnormal results of cervical examination of clinical significance obtained within 1 years prior to screening
  • Abnormal vaginal bleeding of undetermined origin
  • Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
  • Known malformations of the sexual organs incompatible with pregnancy
  • Known current or past (last 12 months) abuse of alcohol or drugs
  • Known history of chemotherapy (except for gestational conditions) or radiotherapy
  • Finding of any clinically relevant abnormal laboratory value
  • Use of any non registered investigational drugs during 3 months before screening or previous participation in the study
  • Pregnancy, lactation or contraindication to pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923194


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China
Navy General Hospital
Beijing, Beijing, China
Peking Union Medical College Hospital
Beijing, Beijing, China
Peking University First Hospital
Beijing, Beijing, China
Peking University People's Hospital
Beijing, Beijing, China
China, Guangdong
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
China, Hubei
Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
China, Liaoning
ShengJing Hospital of China Medical University
Shenyang, Liaoning, China
China, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01923194    
Other Study ID Numbers: 000055
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Anovulation
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs