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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

NCT06173869

Infertility, Female

COMPLETED PHASE3

Low-dose Gonal-f® in Ovulation Induction

NCT01871532

Infertility Monofollicular Development

TERMINATED PHASE4

A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)

NCT01115725

Infertility

COMPLETED

Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

NCT05149924

Infertility

COMPLETED PHASE3

A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

NCT00230815

Infertility

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Anovulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DA-3801 injection

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

Group Type EXPERIMENTAL

DA-3801 Injection

Intervention Type DRUG

Gonal-F®

75 IU/day is injected for 14 days

Group Type ACTIVE_COMPARATOR

Gonal-F®

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DA-3801 Injection

Intervention Type DRUG

Gonal-F®

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No