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The clinical multicentre study for the realitionship of Gestrinone treatment and AUB

The clinical multicentre study for the realitionship of Gestrinone treatment and AUB

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002327
Enrollment
Unknown
Registered
2012-06-25
Start date
2012-04-01
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

adenomyosis, endometriosis

Interventions

1:Gestrinone, 2.5 mg, twice per week, last for 3 months
2:Gestrinone, 2.5 mg, 3 times a week, last for 1 months
then 2.5 mg, twice per week, last for 2 months
3:Gestrinone, 2.5 mg, 3 times a week, last for 3months. It can accompany use Liver protect drug such as Bifendate.

Sponsors

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Sexual life history, 18-45 years of age in premenopausal women; 2. The patients with endometriosis or adenomyosis are diagnosed by clinical or pathological diagnosis standards;Clinical diagnosis standards of pelvic endometriosis: (1) pain(dysmenorrhea, chronic pelvic pain, intercourse pain), infertility; (2) gynecological examination and auxiliary examination: lesions of endometriosis examined by pelvic examination, lesions of endometriosis examined by imaging examination, the level of CA125 increased slightly or moderately; (3) laparoscopy: Laparoscopy is the general method of diagnosis of endometriosis, diagnosis is based on the morphology of lesions, and not all of the lesions can be confirmed by pathological diagnosis. Clinical diagnosis standards of adenomyosis: (1) symptoms (dysmenorrhea, menses increased, infertility), gynecological examination(uterus enlarged, texture coarse); (2) ultrasonography (uterus enlarged,myometrial thickness increased, posterior wall of uterus thickened obviously, endometrium moved forward, equal or strong echo lesions with spotty low echo, lesions with unclear boundary); (3) MRI: lesions with unclear boundary and lower signal intensity, high signal intensity on T2, EMI>12mm; (4) high level of CA125; (5) diagnosised by pathology. The Second is the essential indicator for diagnosis, and with the other one or more standards to can make a clinical diagnosis; 3. Agree to take part in the trial and in accordance with the provisions of the follow-up.

Exclusion criteria

Exclusion criteria: (1) pregnant and lactating women; (2) patients with bilateral oophorectomy; (3) Gestrinone or the reagent containing excipients allergy; (4) Having a history of the metabolic or vascular disease caused by estrogen or progesterone treatment; (5) Suffering from liver disease(AST>60U/ml,ALT>60U/ml); (6) used hormone therapy in last 3 monthes; (7) Suffering from thrombotic disease, coagulation disorders; (8) patients with IUD; (9) patients with dysfunctional uterine bleeding, endometrial sarcomatoid variant, uterine polyps, submucous myoma of uterus cervical polyps; (10) not sign the informed consent; (11) poor compliance, nor follow-up.

Design outcomes

Primary

MeasureTime frame
Vaginal bleeding mode and time;

Countries

China

Contacts

Public ContactDuan Hua
wx_0327@126.com+86 13501019066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026