Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: Norethisterone,Ethinylestradiol; Drug: Sugar pill

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212342

IKH-01-4

Details and patient eligibility

About

The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.

Enrollment: 100 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups, including a placebo group

Norethisterone,Ethinylestradiol

Experimental group

Treatment:

Drug: Norethisterone,Ethinylestradiol

Sugar pill

Placebo Comparator group

Treatment:

Drug: Sugar pill