New User Registry of Hormone Replacement Therapy and Long-Term Follow-up Study in Japan

Japan Society for Menopause and Women's Health Hormone Replacement Therapy Database Project - JHDP - - Registry of hormone replacement therapy and long-term follow-up study - - JHDP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045133

Enrollment

60000

Registered

2021-08-12

Start date

2021-07-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

postmenopausal disorders

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women who are newly starting hormone replacement therapy for the prevention or treatment of symptoms or diseases associated with estrogen deficiency. Women who are able to give written consent to cooperate in the long-term follow-up survey Women who are able to participate in the follow-up survey via smartphone.

Exclusion criteria

Exclusion criteria: Women for whom hormone replacement therapy is contraindicated - Severe active liver disease - Current breast cancer and history of breast cancer - Current endometrial cancer, low-grade endometrial stromal sarcoma - Unexplained abnormal uterine bleeding - Suspected pregnancy - Acute thrombophlebitis or venous thromboembolism and history thereof - History of myocardial infarction and atherosclerotic lesions in coronary arteries - History of stroke Women who have received hormone replacement therapy by the time of enrollment

Design outcomes

Primary

Measure	Time frame
cancer incidence and mortality (breast cancer, ovarian cancer, endometrial cancer, cervical cancer, colorectal cancer, etc.) (6 months, 1 year, 2 years, 3 years, 4 years, 5 years after study start)	—

Secondary

Measure	Time frame
HRT regimen Patient quality of life Cardiovascular disease incidence and mortality (myocardial infarction, angina pectoris, subarachnoid hemorrhage, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism) Changes in menopausal symptoms according to the Japanese Society of Obstetrics and Gynecology Menopausal Symptom Assessment Table Changes in bone mineral density and incidence of pathological fracture Changes in obesity, body weight, lipid profile, and blood pressure levels Adverse events (abnormal uterine bleeding, breast distension, headache, abnormal laboratory values, others)	—

Measure

Time frame

HRT regimen Patient quality of life Cardiovascular disease incidence and mortality (myocardial infarction, angina pectoris, subarachnoid hemorrhage, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism) Changes in menopausal symptoms according to the Japanese Society of Obstetrics and Gynecology Menopausal Symptom Assessment Table Changes in bone mineral density and incidence of pathological fracture Changes in obesity, body weight, lipid profile, and blood pressure levels Adverse events (abnormal uterine bleeding, breast distension, headache, abnormal laboratory values, others)

—

Countries

Japan

Contacts

Public ContactMieko Nobusawa

The Japan Society for Menopause and Women's Health secretariat

jmwh@congre.co.jp03-3510-3748

Outcome results