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

Anovulation Clinical Trial

— Compass  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923194
• Other study ID #: 000055
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2013
• Last updated: August 20, 2015
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anovulation

Intervention

Drug:
• Highly Purified Urofollitropin
for Injection
• Recombinant Human Follitropin Alfa
for Injection

Locations

Country	Name	City	State
China	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	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Sun Yat-sen Memorial Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	ShengJing Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ovulation rate defined as the percentage of subjects who present ovulation		From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration	No
Secondary	The positive serum progesterone rate		6~9 days post hCG administration	No
Secondary	The positive serum ß-hCG/hCG rate		18~22 days post hCG administration	No
Secondary	The clinical pregnancy rate	Regardless of fetal heart beat	6~7 weeks post hCG administration	No
Secondary	The clinical pregnancy rate	With fetal heart beat	6~7 weeks post hCG administration	No
Secondary	The ongoing pregnancy rate		11~12 weeks post hCG administration	No
Secondary	The follicular development		On the day of hCG administration	No
Secondary	Endometrial thickness		On the day of hCG administration	No
Secondary	Total FSH (Follicle-stimulating hormone) dose administered		On the day of hCG administration	No
Secondary	Number of FSH treatment days		On the day of hCG administration	No
Secondary	Frequency and severity of adverse events		Expected maximum of 6 months	Yes
Secondary	Frequency and severity of injection site reactions		Day 1 up to Day 28 of the ovarian stimulation period	Yes
Secondary	Serum estradiol (E2) levels		On the day of hCG administration	No