Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial

This placebo-controlled, double-blind, randomized trial showed the efficacy and safety of an ultra-low dose OC (0.02 mg ethinyl estradiol and 1 mg norethisterone) in patients with dysmenorrhea.

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Volume 106, Issue 7, Pages 1807-1814

Authors:

Tasuku Harada, M.D., Mikio Momoeda, M.D.

Abstract:

Objective

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea.

Design

Placebo-controlled, double-blind, randomized trial.

Setting

Clinical trial sites.

Patient(s)

Two hundred fifteen subjects with dysmenorrhea.

Intervention(s)

Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles.

Main Outcome Measure(s)

Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics.

Result(s)

The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred.

Conclusion(s)

The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea.

Clinical Trial Identification Number

NCT01129102.


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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