Phase 2 N=141 Randomized Single-blind Prevention

Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Asherman Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02726971 ↗

Enrolled (actual)

141

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: the AFS Score at Second-look Hysteroscopy — 1.6; 1.9 units on a scale — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Femoston (Drug)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Fu Xing Hospital, Capital Medical University
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY the AFS Score at Second-look Hysteroscopy	1.6; 1.9	>0.05
SECONDARY the AFS Score at Third-look Hysteroscopy	1.0; 1.2	—
SECONDARY Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy	38; 44	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02726971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.