An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225090

Enrollment

Registered

2020-02-27

Start date

2020-04-22

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

endometriosis

Interventions

investigational material(s) Generic name etc : FSN-013 INN of investigational material : Estetrol/Drospirenone Therapeutic category code : 248 Mixed hormone preparations Dosage and Administration for

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Japanese patients, diagnosed as endometriosis by laparotomy/laparoscopy, and/or as having ovarian chocolate cysts by TVUS or MRI 2. Aged >= 20 and < 50 years 3.BMI < 30 kg/m2

Exclusion criteria

Exclusion criteria: 1. Undiagnosed abnormal vaginal bleeding 6 months before the screening tests 2. Aged >= 40 years with ovarian chocolate cyst for which the largest diameter was > 10 cm 3. Ovarian chocolate cyst containing solid components 4. Had undergone surgical treatment for endometriosis by cyst puncture (such as transvaginal alcohol fixation), laparotomy, or laparoscopy (laparoscopy) within 2 months prior to the screening tests

Design outcomes

Primary

Measure	Time frame
pharmacodynamics Severest pelvic pain (VAS)	—

Secondary

Measure	Time frame
safety exploratory pharmacokinetics pharmacodynamics Gynecological examination Hemostasis and related parameters Endocrine parameters	—

Countries

Japan

Outcome results

None listed

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