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A prospective, multicenter and randomized parallel control study on the treatment of uterine volume inducing by different Leuprorelin Acetate microspheres doses (Enantone?R) in adenomyosis.

The effect of different Leuprorelin Acetate microspheres doses (Enantone?R) to uterine volume in adenomyosis.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005971
Enrollment
Unknown
Registered
2015-02-11
Start date
2014-06-30
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

Interventions

Fertility group1:Enantone 3.75mg
Fertility group2:Enantone 1.88mg
Small Uterus and fertility needless group1:Mirena
Small Uterus and fertility needless group2:oral contraceptive
Small Uterus and fertility needless group3:San Jie Zhen Tong capsule
Large Uterus and fertility needless group1:Enantone 3.75mg
Large Uterus and fertility needless group2:Enantone 1.88mg

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 50 Years

Inclusion criteria

Inclusion criteria: Be voluntory to this trial and sign the consent form; Women age between 25 to 50; B-Ultrasound indicate adenomyosis; Dysmenorrhea; Maxium diameter of Uterine is less than or equal to 10cm.

Exclusion criteria

Exclusion criteria: Younger than 25, elder than 50 or postmenopausal women; Be allergic to or contraindicated to studied drugs; Be pregnant, having accute genital tract inflamation or other gynecological malignant diseases such as ovarian cancer; Receive progestin treatment within a month, receive GnRH-a within three months, or underwent uterus within six months; Severe hepatic and renal dysfunction; CA125>300U/mL.

Design outcomes

Primary

MeasureTime frame
CA125;FSH;LH;E2;uterrine size;

Countries

China

Contacts

Public ContactHua Keqin
huakeqin@126.com+86 15921515900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026