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Evaluation of Therapeutic Effect and Safety of RU-486 in the Treatment of Adenomyosis with pain

Evaluation of Therapeutic Effect and Safety of RU-486 in the Treatment of Adenomyosis and Endometriosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16007815
Enrollment
Unknown
Registered
2016-01-22
Start date
2015-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriosis and adenomyosis

Interventions

1:2.5mg RU-486 po qd *12 months
2:5mg RU-486 po qd*12 months
3:25mg RU-486 po qw*11 months

Sponsors

Women's Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) female, aged >=18, agree to the RU - 486 treatment and signed informed consent; (2) the preoperative vaginal ultrasound and/or nuclear magnetic resonance (MRI) confirmed as a diffuse wall after the front wall of the uterus, and/or glandular myopathy, cause myometrium diffuse thickening obviously; (3) severe dysmenorrhea with menorrhagia; (4) placed separately LNG-IUS invalid or failure, including oral contraceptive drugs; (5) requires the uterus or fertility; (6) 3 months before drug treatment, did not accept other hormonal drug therapy for adenomyosis.

Exclusion criteria

Exclusion criteria: 1. is participating in other clinical trials of patients; 2. the researchers think the other reasons are not suitable for clinical subjects, as follows: (1) the endometrium cervical breast malignant diseases; (2) with serious heart, liver, kidney function disorder; (3) according to the researchers evaluation, the existing patients may as a result of the drug treatment and disease; (4) pregnancy or lactation in the three months before the start of treatment had childbirth, abortion or lactation); (5) going to pregnancy within the established treatment period; (6) body mass index (BMI) > 30 kg/m2; (7) allergic to study drug ingredients.

Design outcomes

Primary

MeasureTime frame
pain;hypermenorrhea;the volumn and length of uterus;endometrial thickness;biochemistry and hormone;life quality score;

Countries

China

Contacts

Public ContactXinmei Zhang
zxm20130729@163.com+86 18957110072

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026