InfertilityPhase 3NCT01820728
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
A Phase 3 study testing DA-3801 Injection and Gonal-F® in people with Infertility and Anovulation, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
open label, active-controlled, randomized, parallel group, comparative study. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility, Anovulation
- What is being tested?
- DA-3801 Injection and Gonal-F®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Oct 2012
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- WHO group II
- Clomiphene citrate resistance
- BMI: 17~29 kg/m^2
- Irregular menstrual cycle
- Normal blood concentration of FSH, E2, prolactin and TSH
Who cannot join
- Uncontrolled endocrine disease
- Ovarian cystic tumor which are NOT related to PCOS
- Severe endometriosis
- Chronic cardiovascular disease, liver complaint
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Institutional Review Board
Seoul, 110-744
About this study
Official title: A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome
open label, active-controlled, randomized, parallel group, comparative study.
Read the detailed description
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
- Conditions
- Infertility, Anovulation
- Being tested
- DA-3801 Injection, Gonal-F®
- Medical subject headings
- Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-3801 InjectionDrug
Gonal-F®Drug
| Study group | Role | What they receive |
|---|---|---|
| DA-3801 injection | Experimental | Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days Receives: Drug: DA-3801 Injection |
| Gonal-F® | Active comparator | 75 IU/day is injected for 14 days Receives: Drug: Gonal-F® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ovulation rate after 3 cycles of the injection
Measured: 5 weeks maximum
Secondary outcomes (4)
Total dose used, IU (International Unit)
Measured: 5 weeks
Duration of stimulation, days
Measured: 5 weeks
Threshold dose, IU
Measured: 5 weeks
Number of follicles
Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJan 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eung Gi Min, M.D., Ph.D., Principal investigator, Dongguk University HospitalChang Suk Suh, M.D., Ph.D., Principal investigator, Seoul National University Bundang HospitalDoo Seok Choi, M.D., Ph.D., Principal investigator, Samsung Medical CenterChung Hoon Kim, M.D., Ph.D., Principal investigator, Asan Medical CenterJong Min Park, M.D.,Ph.D., Principal investigator, Gachon University Gil Medical CenterKyung Joo Hwang, M.D., Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820728
- Sponsor's protocol ID
- DA3801_CA_III (Version 5.1)
- Status last verified
- Apr 2021
- First submitted
- 18 Mar 2013
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome
- ClinicalTrials.gov ID
- NCT01820728
- Acronym / sponsor ID
- DA3801_CA_III (Version 5.1)
- Conditions
- Infertility, Anovulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Mar 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.
open label, active-controlled, randomized, parallel group, comparative study.
Detailed description
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-3801 injection | Experimental | Drug: DA-3801 InjectionRecominant human follicle stimulating hormone 75 IU/day is injected for 14 days |
| Gonal-F® | Active comparator | Drug: Gonal-F®75 IU/day is injected for 14 days |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- WHO group II
- Clomiphene citrate resistance
- BMI: 17~29 kg/m^2
- Irregular menstrual cycle
- Normal blood concentration of FSH, E2, prolactin and TSH
Key exclusion criteria (4 listed)
- Uncontrolled endocrine disease
- Ovarian cystic tumor which are NOT related to PCOS
- Severe endometriosis
- Chronic cardiovascular disease, liver complaint
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 |
|---|---|---|
| DA-3801 Injection | Drug | DA-3801 injection |
| Gonal-F® | Drug | Gonal-F® |
Primary outcome
The ovulation rate after 3 cycles of the injection
Time frame: 5 weeks maximum
4 secondary outcomes
Total dose used, IU (International Unit)
Time frame: 5 weeks
Duration of stimulation, days
Time frame: 5 weeks
Threshold dose, IU
Time frame: 5 weeks
Number of follicles
Time frame: 5 weeks
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 15 Apr 2021.
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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.
Eung Gi Min, M.D., Ph.D. principal investigator
Dongguk University Hospital
Chang Suk Suh, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
Doo Seok Choi, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-3801 Injection and Gonal-F® in people with Infertility and Anovulation, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
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 5 inclusion and 4 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 after 3 cycles of the injection (time frame: 5 weeks maximum). 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 15 Apr 2021.