CompletedPhase 3

A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

South Korea93 participantsStarted 2007-01

Plain-language summary

open label, active-controlled, randomized, parallel group, comparative study.

Who can participate

Age range20 Years – 38 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * WHO group II * Clomiphene citrate resistance * BMI: 17\~29 kg/m\^2 * Irregular menstrual cycle * Normal blood concentration of FSH, E2, prolactin and TSH Exclusion Criteria: * Uncontrolled endocrine disease * Ovarian cystic tumor which are NOT related to PCOS * Severe endometriosis * Chronic cardiovascular disease, liver complaint

What they're measuring

The ovulation rate after 3 cycles of the injection

Timeframe: 5 weeks maximum

Trial details

NCT IDNCT01820728

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

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