A study of FSN-013 in Japanese patients with dysmenorrhea

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Cyclic Oral Administration of FSN-013 (E4/DRSP) in Japanese Patients With Dysmenorrhea

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011210023

Enrollment

150

Registered

2021-07-28

Start date

2021-08-02

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

dysmenorrhea

Interventions

FSN-013 or Placebo administered orally

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Secondary dysmenorrhea -Diagnosed as Endometriosis or Adenomyosis by laparotomy or laparoscopy -Diagnosed as Endometriosis with ovarian chocolate cysts or Adenomyosis or Uterine fibroids by TVUS or MRI 2.Functional dysmenorrhea -Patients whose secondary dysmenorrhea was ruled out by history taking, vaginal examination, and TVUS, etc. 3.Aged >= 20 years at the time of informed consent 4.BMI < 30 kg/m2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The amount of change in the total dysmenorrhea score	—

Contacts

Public ContactToshiaki Takayanagi

Fuji Pharma Co., Ltd.

clinical_trials@fujipharma.jp+81-3-3556-3344

Outcome results

None listed

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