Clinical trial NCT01923194: Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anovulation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 215
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The ovulation rate defined as the percentage of subjects who present ovulation
timeFrame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration
Secondary outcomes:
measure: The positive serum progesterone rate
timeFrame: 6~9 days post hCG administration
measure: The positive serum β-hCG/hCG rate
timeFrame: 18~22 days post hCG administration
measure: The clinical pregnancy rate
timeFrame: 6~7 weeks post hCG administration
measure: The clinical pregnancy rate
timeFrame: 6~7 weeks post hCG administration
measure: The ongoing pregnancy rate
timeFrame: 11~12 weeks post hCG administration
measure: The follicular development
timeFrame: On the day of hCG administration
measure: Endometrial thickness
timeFrame: On the day of hCG administration
measure: Total FSH (Follicle-stimulating hormone) dose administered
timeFrame: On the day of hCG administration
measure: Number of FSH treatment days
timeFrame: On the day of hCG administration
measure: Frequency and severity of adverse events
timeFrame: Expected maximum of 6 months
measure: Frequency and severity of injection site reactions
timeFrame: Day 1 up to Day 28 of the ovarian stimulation period
measure: Serum estradiol (E2) levels
timeFrame: On the day of hCG administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: