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Reverse addition protocol after endometriosis surgery

The efficacy and safety of GnRH-a combined with low-dose estradiol and dydrogesterone tablets in reverse addition after conservative surgery for moderate to severe endometriosis: A multicenter randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124622
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

endometriosis

Interventions

group A:Low-dose estradiol and dydrogesterone tablets 1 tablet per day orally
group B:Tibolone 1.25mg orally per day

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 45 who have not reached menopause and were diagnosed with stage III/IV endometriosis by laparoscopy (with the uterus preserved), pathologically confirmed to have endometriosis, and after comprehensive assessment by clinicians, need to receive GnRH-a treatment for 6 months. 2. Agree to receive the drug treatment in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with serious cardiovascular and cerebrovascular diseases, diabetes, hypertension, liver and kidney insufficiency and other basic diseases; 2. Previous or current history of malignant tumor; 3. Presence of untreated endometrial dysplasia; 4. Patients with previous or current venous thrombosis (deep vein thrombosis, pulmonary embolism, etc.); 5. Patients with poor compliance; 6. Use of estrogen or estrogen-acting drugs within one month; 7. Long-term use of hormone drugs; 8. GnRH-a treatment was given within one month before surgery.

Design outcomes

Primary

MeasureTime frame
Modified Menopause Index score;

Secondary

MeasureTime frame
EQ-5D-5L score;Pittsburgh Sleep Quality Index;bone mineral density;estrogen;luteinizing hormone ;follicle-stimulating hormone;anti-mullerian hormone;The degree of pelvic pain;endometrial thickness;

Countries

China

Contacts

Public ContactWang Ping

West China Second University Hospital, Sichuan University

wangping_886@126.com+86 189 8086 4881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026