Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

NCT ID: NCT02726971

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

Brief Summary

This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.

Conditions

Asherman Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low dose of oestrogen

Patients in this group will build artificial cycle by Femoston.(oral one red tablet daily for 11 days and oral one yellow tablet in the next 10 days). This process will last for 3 months after the surgery.

P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.

Group Type: EXPERIMENTAL

Femoston

Intervention Type: DRUG

Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

High dose of oestrogen

Patients in this group will build artificial cycle by Femoston.(oral three red tablets daily for 11 days and oral two yellow tablets in the next 10 days). This process will last for 3 months after the surgery.

P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.

Group Type: ACTIVE_COMPARATOR

Femoston

Intervention Type: DRUG

Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Interventions

Femoston

Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);

2. Scheduled for hysteroscopic adhesiolysis;

3. Agreed to have two follow-up hysteroscopy; and

4. Written, informed consent obtained.

Exclusion Criteria

1. Received estrogen therapy within 3 months of enrollment;

2. Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);

3. History of genital tuberculosis; and

4. Contraindication for estrogen therapy.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fu Xing Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Guo

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fu Xing Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

LYuhuan

Identifier Type: -

Identifier Source: org_study_id