Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

NCT02726971 | Completed Phase 1 Results DMC

• 1 other identifier: LYuhuan
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Keywords

Intrauterine Adhesion; Oestrogen Artificial Periodic Therapy

Outcome Measures

Primary Outcomes (1)

• the AFS Score at Second-look Hysteroscopy

  The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

  1 months after the surgery

Secondary Outcomes (2)

• the AFS Score at Third-look Hysteroscopy

  2 months after surgery

• Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy

  3 months after surgery

Study Arms (2)

Low dose of oestrogen

EXPERIMENTAL

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.

Drug: Femoston

High dose of oestrogen

ACTIVE COMPARATOR

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.

Drug: Femoston

Interventions

Femoston DRUG

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

High dose of oestrogen; Low dose of oestrogen

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
• Scheduled for hysteroscopic adhesiolysis;
• Agreed to have two follow-up hysteroscopy; and
• Written, informed consent obtained.

You may not qualify if:

• Received estrogen therapy within 3 months of enrollment;
• Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
• History of genital tuberculosis; and
• Contraindication for estrogen therapy.

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Fu Xing Hospital,Capital Medical University

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Gynatresia

Interventions

femoston

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. YH Liu
• Organization: Department of Hysteroscopic Center, Fuxing Hospital, Capital Medical University, Beijing, China

emmagj@126.com

8618301474064

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 4, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)