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The establishment of a novel immobilized levonorgestrel sustained-release system and its mechanism in the treatment of adenomyosis

The establishment of a novel immobilized levonorgestrel sustained-release system and its mechanism in the treatment of adenomyosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114219
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Adenomyosis

Interventions

Treatment group:The patients in the treatment group were treated with 2 / 0 Prolene suture to fix LNG-IUS ( Mirena, Germany, Bayer, 52ug ) at the bottom of the uterus by two gynecologists above the ti
Control group:The control group was placed with Mirena by two gynecologists above the title of deputy director using conventional methods after the sixth needle GnRh-a treatment.

Sponsors

Jin Hua People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1 ) 30 <= age <= 50 years old, women with a history of sexual life ; 2 ) Patients who met the diagnostic criteria of adenomyosis by imaging examination ; 3 ) Patients who were willing to participate in this study and signed informed consent ; 4 ) Patients with adenomyosis who refused hysterectomy. 5 ) In the past six months, hormone drugs were not used and drug therapy was agreed to be used.

Exclusion criteria

Exclusion criteria: 1 ) Patients with contraindications of progesterone therapy and hysteroscopy, including severe coagulation dysfunction, severe heart, liver, kidney disease or mental disorders ; 2 ) Female genital tuberculosis, inflammation, endometrial polyps, submucous myoma of uterus, endometrial cancer patients ; 3 ) Postmenopausal status ; 4 ) Patients with a history of LNG-IUS treatment within 1 year ; 5 ) Patients who were considered unsuitable for other reasons by medical staff.

Design outcomes

Primary

MeasureTime frame
LNG-IUD in place time;

Secondary

MeasureTime frame
Uterine volume size;Time of post-operational vaginal bleeding;MBLS score of menstrual volume after treatment ( number of days with more menstrual volume / total number of days of menstruation × number of sanitary napkins used );VAS after treatment;LNG-IUD expulsion n(%);

Countries

China

Contacts

Public ContactXu Pan

Jin Hua People's Hospital

xupan033@163.com+86 150 5784 8308

Outcome results

None listed

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