Overview

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

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Follicle Stimulating Hormone
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