The efficacy and safety of Dydrogesterone for treatment of Dysmenorrhea

Dysmenorrhea, or menstrual pain, is the most common menstrual symptom among adolescent girls and young women.

Most adolescents experiencing dysmenorrhea have primary dysmenorrhea, defined as painful menstruation in the absence of pelvic pathology. Primary dysmenorrhea characteristically begins when adolescents attain ovulatory cycles, usually within 6–12 months of menarche.

Secondary dysmenorrhea refers to painful menses due to pelvic pathology or a recognized medical condition.

The most common cause of secondary dysmenorrhea is endometriosis.

Most adolescents who present with dysmenorrhea have primary dysmenorrhea and will respond well to empiric treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or hormonal suppression, or both. However, some patients either present initially with symptoms suggesting secondary dysmenorrhea or they fail empiric treatment for primary dysmenorrhea and require further evaluation.

Pelvic imaging with ultrasonography, regardless of findings on pelvic examination, also should be considered during evaluation for secondary dysmenorrhea.

Therapy must be individualized, and obstetrician–gynecologists should consider patient choice, the need for contraception, contraindications to hormone use, and potential adverse effects and counsel the adolescent and her family on treatment options.

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The study aims to evaluate the efficacy and safety of dydrogesterone in Japanese women with dysmenorrhea. One dydrogesterone 5-mg tablet was administered orally twice daily for 21 days from the 5th to 25th day of each menstrual cycle.

Dysmenorrhea went down over time following the administration of dydrogesterone, and the decrease was statistically significant at and after 2nd cycle of menstruation.

Severity of menstruation-related lower abdominal pain, low back pain, headache, and nausea/vomiting, in the evaluated menstruation cycles tended to decrease over time.

Conclusion: Dydrogesterone is efficacious, safe, and clinically beneficial in patients with dysmenorrhea, thereby indicating that dydrogesterone can be considered as a treatment option for patients with dysmenorrhea.

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Abstract

Aims: Dydrogesterone is a retro-progesterone preparation widely used for over a half century. Authors sought to evaluate the efficacy and safety of dydrogesterone in Japanese women with dysmenorrhea.

Methods: This study was conducted as an open-label, single-arm, multicenter study. One dydrogesterone 5-mg tablet was administered orally twice daily for 21 days from the 5th to 25th day of each menstrual cycle. A total of 44 (safety analysis) and 31 patients (efficacy analysis) were enrolled. Total dysmenorrhea score, dysmenorrhea subscale scores, dysmenorrhea visual analog scale, severity of menstruation-related lower abdominal pain, low back pain, headache, and nausea/vomiting, basal body temperature, and serum estradiol and progesterone levels were evaluated.

Results: Baseline of the total dysmenorrhea score was 4.61, which went down over time following the administration of dydrogesterone, and the decrease was statistically significant at and after 2nd cycle of menstruation. Mean change from baseline at the final evaluation point was -1.84. Severity of menstruation-related lower abdominal pain, low back pain, headache, and nausea/vomiting, in the evaluated menstruation cycles tended to decrease over time. Basal body temperature showed a biphasic pattern in 70% at baseline, 50% in 2nd menstruation cycle, and 61% in 5th menstruation cycle, and at least half of the patients may have had ovulation during the treatment. Incidence of adverse drug reactions was 31.8%, and the most common adverse event was metrorrhagia.