A Phase 3 interventional study of DA-3801 Injection and Gonal-F® in Infertility and Anovulation, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Dong-A ST Co., Ltd. · Phase 3, Interventional, and Treatment
open label, active-controlled, randomized, parallel group, comparative study.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 93 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days
Drug: DA-3801 Injection
75 IU/day is injected for 14 days
Drug: Gonal-F®
The ovulation rate after 3 cycles of the injection
Time frame: 5 weeks maximum
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
Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Time frame: 5 weeks
The record gives a start of Jan 2007, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.