Clinical trial · Interventional
Multi-centre Clinical Trial on Hormone Replacement Treatment in China
NCT01698164CI-TRIAL-00008188unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiovascular Disease | — | UNRESOLVED | — |
| Menopausal Syndrome | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| estradiol plus MPA | Drug | — | UNRESOLVED |
| estradiol plus progesterone | Drug | — | UNRESOLVED |
| Ximingting Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- estradiol plus MPA
- description
- 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg\*21/box medroxyprogesterone acetate, 2mg\*100/bottle
- interventionNames
- Drug: estradiol plus MPA
- type
- EXPERIMENTAL
- label
- estradiol plus progesterone
- description
- 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg\*21/box progesterone capsule, 100mg\*6/box
- interventionNames
- Drug: estradiol plus progesterone
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * going through amenorrhea above 6 months and within 5 years, * aged 40 to 60 years, * going though postmenopausal symptoms, * serum E2 concentration \<30pg/ml, * serum FSH concentration \>40IU/L. Exclusion Criteria: * uterine fibroid diameter≥5cm, * history of diabetes or hypertension, * history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia, * first degree relative had a history of breast cancer, * being in severe or unstable condition of somatic diseases, * receiving HRT in the past 3 month, * drug or alcohol abuse in the past 3 month, * endometrial thickness ≥0.5cm after withdrawal bleeding, * being allergic to the medicine, * participating in other clinical trials within 1 month ago.
References
Publications (1)
- DERIVEDXue W, Deng Y, Wang YF, Sun AJ. Effect of Half-dose and Standard-dose Conjugated Equine Estrogens Combined with Natural Progesterone or Dydrogesterone on Components of Metabolic Syndrome in Healthy Postmenopausal Women: A Randomized Controlled Trial. Chin Med J (Engl). 2016 Dec 5;129(23):2773-2779. doi: 10.4103/0366-6999.194646. PMID 27900987