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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Infertility; Anovulation

Treatments: Drug: Gonal-F®; Drug: DA-3801 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820728

DA3801_CA_III (Version 5.1)

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

DA-3801 injection

Experimental group

Description:

Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days

Treatment:

Drug: DA-3801 Injection

Gonal-F®

Active Comparator group

Description:

75 IU/day is injected for 14 days

Treatment:

Drug: Gonal-F®