UnknownNot Applicable

A Multicenter, Observational Clinical Study of Dydrogesterone

China400 participantsStarted 2023-01-01

Plain-language summary

The objective of this study was to investigate the efficacy and safety of dydrogesterone in the long-term management of ovarian endometriosis cyst after surgery.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who had undergone laparoscopic ovarian cyst excision and were confirmed by pathological diagnosis as ovarian endometriosis cyst (pathology was completed in each central hospital). * Ovarian cyst \>4cm. * Concomitant infertility. * Patients who fail to respond to medication. * American Society of Reproductive Medicine(ASRM) stages were II-IV. * No relevant therapeutic drugs, such as dydrogesterone, dienogest, GnRHa, etc., were used 3 months before treatment. * No combined endocrine diseases. Exclusion Criteria: * Ovulation disorders, immune defects and genital development abnormalities caused by infertility. * Patients who are allergic to the drugs used in this study. * Patients with severe hepatorenal insufficiency or malignant tumor. * Those who took hormone medication within 3 months before the study date.

What they're measuring

Visual analogue pain score(VAS)

Timeframe: before drug treatment and 3 months after drug treatment

Endometriosis fertility index(EFI)

Timeframe: before drug treatment and 3 months after drug treatment

The Cox Menstrual Symptom Scale(CMSS)

Timeframe: before drug treatment and 3 months after drug treatment

Trial details

NCT IDNCT05976529

SponsorGuangdong Women and Children Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

Contact for this trial

Li Li, M.D.

+86 13631446859 lili-1406@163.com

View on ClinicalTrials.gov More Endometriosis trials