Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: NPC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902746

NPC-01-1

Details and patient eligibility

About

The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.

Enrollment: 149 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dysmenorrhea associated with endometriosis

Exclusion criteria

• Severe hepatopathy
• Pregnant woman

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

149 participants in 1 patient group

NPC-01

Experimental group

Description:

Norethisterone, Ethinyl Estradiol

Treatment:

Drug: NPC-01