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

Ferring

Status and phase

Completed

Phase 3

Conditions

Anovulation

Treatments

Drug: Highly Purified Urofollitropin

Drug: Recombinant Human Follitropin Alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01923194

000055

Details and patient eligibility

About

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

Enrollment

215 patients

Sex

Female

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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