Open label study of FSN-011-01 in Japanese women with menopausal disorder with uterus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223763

Enrollment

300

Registered

2017-12-25

Start date

2018-03-01

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

Assistance of hormone replacement therapy (HRT) in menopausal non-hysterectomized women

Interventions

investigational material(s) Generic name etc : FSN-011-01 INN of investigational material : Progesterone Therapeutic category code : 247 Estrogen and gestagen preparations Dosage and Administration fo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Japanese menopausal women with uterus to undergo hormone replacement therapy

Exclusion criteria

Exclusion criteria: -Subjects who are positive or indeterminable with 5 mm or more of endometrial thickness in endometrial biopsy -Subjects who are not able to undergo endometrial biopsy procedurally due to cervical stenosis, etc. at screening (Visit 1). -Subjects who have serious liver injury at screening (Visit 1) -Subjects who have or are suspected to have malignant tumor at screening (Visit 1) -Subjects who have past medical history of breast cancer

Design outcomes

Primary

Measure	Time frame
efficacy Incidence of endometrial hyperplasia	—

Secondary

Measure	Time frame
efficacy Endometrial thickness	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026