NCT01923194|CompletedPhase 3

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

Compass

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

Ferring Pharmaceuticals ClinicalTrials.gov

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1 other identifier

000055

Study Type

interventional

Target

215

Locations

1 country

Sites

Timeline

RegisteredAug 2013

StartedOct 2013

CompletionAug 2015

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

215

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2013

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

August 12, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed

Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

August 12, 2013

Last Update Submit

August 20, 2015

Conditions

Anovulation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

The positive serum progesterone rate
6~9 days post hCG administration
The positive serum β-hCG/hCG rate
18~22 days post hCG administration
The clinical pregnancy rate
6~7 weeks post hCG administration
The clinical pregnancy rate
6~7 weeks post hCG administration
The ongoing pregnancy rate
11~12 weeks post hCG administration
+7 more secondary outcomes

Study Arms (2)

Test Group

EXPERIMENTAL

Drug: Highly Purified Urofollitropin

Comparator Group

ACTIVE COMPARATOR

Drug: Recombinant Human Follitropin Alfa

Interventions

Highly Purified UrofollitropinDRUG

for Injection

Also known as: Bravelle®

Test Group

Recombinant Human Follitropin AlfaDRUG

for Injection

Also known as: Gonal-F®

Comparator Group

Eligibility Criteria

Age20 Years - 39 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.