AnovulationPhase 3CompassNCT01923194
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
A Phase 3 study testing Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa in people with Anovulation, run by Ferring Pharmaceuticals at 12 sites in China.
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 Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Anovulation
- What is being tested?
- Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 12 sitesChina
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality
Navy General Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
ShengJing Hospital of China Medical University
Shenyang, Liaoning
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei
About this study
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
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
- Conditions
- Anovulation
- Being tested
- Highly Purified Urofollitropin, Recombinant Human Follitropin Alfa
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly Purified UrofollitropinDrug
Also called Bravelle®
for Injection
Recombinant Human Follitropin AlfaDrug
Also called Gonal-F®
for Injection
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Drug: Highly Purified Urofollitropin |
| Comparator Group | Active comparator | Not described Receives: Drug: Recombinant Human Follitropin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ovulation rate defined as the percentage of subjects who present ovulation
Measured: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration
Secondary outcomes (12)
The positive serum progesterone rate
Measured: 6~9 days post hCG administration
The positive serum β-hCG/hCG rate
Measured: 18~22 days post hCG administration
The clinical pregnancy rate
Regardless of fetal heart beat
Measured: 6~7 weeks post hCG administration
The clinical pregnancy rate
With fetal heart beat
Measured: 6~7 weeks post hCG administration
The ongoing pregnancy rate
Measured: 11~12 weeks post hCG administration
The follicular development
Measured: On the day of hCG administration
Endometrial thickness
Measured: On the day of hCG administration
Total FSH (Follicle-stimulating hormone) dose administered
Measured: On the day of hCG administration
Number of FSH treatment days
Measured: On the day of hCG administration
Frequency and severity of adverse events
Measured: Expected maximum of 6 months
Frequency and severity of injection site reactions
Measured: Day 1 up to Day 28 of the ovarian stimulation period
Serum estradiol (E2) levels
Measured: On the day of hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923194
- Sponsor's protocol ID
- 000055
- Acronym
- Compass
- Status last verified
- Aug 2015
- First submitted
- 12 Aug 2013
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01923194
- Acronym / sponsor ID
- Compass / 000055
- Conditions
- Anovulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Highly Purified Urofollitropin |
| Comparator Group | Active comparator | Drug: Recombinant Human Follitropin Alfa |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly Purified UrofollitropinAlso: Bravelle®for Injection | Drug | Test Group |
| Recombinant Human Follitropin AlfaAlso: Gonal-F®for Injection | Drug | Comparator Group |
Primary outcome
The ovulation rate defined as the percentage of subjects who present ovulation
Time frame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration
12 secondary outcomes
The positive serum progesterone rate
Time frame: 6~9 days post hCG administration
The positive serum β-hCG/hCG rate
Time frame: 18~22 days post hCG administration
The clinical pregnancy rate
Time frame: 6~7 weeks post hCG administration
The clinical pregnancy rate
Time frame: 6~7 weeks post hCG administration
The ongoing pregnancy rate
Time frame: 11~12 weeks post hCG administration
The follicular development
Time frame: On the day of hCG administration
Endometrial thickness
Time frame: On the day of hCG administration
Total FSH (Follicle-stimulating hormone) dose administered
Time frame: On the day of hCG administration
Number of FSH treatment days
Time frame: On the day of hCG administration
Frequency and severity of adverse events
Time frame: Expected maximum of 6 months
Frequency and severity of injection site reactions
Time frame: Day 1 up to Day 28 of the ovarian stimulation period
Serum estradiol (E2) levels
Time frame: On the day of hCG administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa in people with Anovulation, run by Ferring Pharmaceuticals at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ovulation rate defined as the percentage of subjects who present ovulation (time frame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.