Elsevier

Fertility and Sterility

Volume 116, Issue 6, December 2021, Pages 1568-1577
Fertility and Sterility

Original article
Prolonged cyclical and continuous regimens of dydrogesterone are effective for reducing chronic pelvic pain in women with endometriosis: results of the ORCHIDEA study

https://doi.org/10.1016/j.fertnstert.2021.07.1194Get rights and content
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open access

Objective

To compare the effectiveness of two different treatment regimens of dydrogesterone in the management of endometriosis-related chronic pelvic pain.

Design

Observational, prospective cohort study over six months.

Setting

Twenty gynecology clinics in the Russian Federation.

Patient(s)

Three hundred fifty women from 18 to 45 years of age with endometriosis and chronic pelvic pain with or without dysmenorrhea.

Intervention(s)

Dydrogesterone 10 mg 2 or 3 times daily, either between the 5th and 25th days of the menstrual cycle (prolonged cyclical treatment regimen) or continuously (continuous treatment regimen). For all patients, the data cutoff was at six months of treatment.

Main Outcome Measure(s)

Intensity of chronic pelvic pain on the 11-point numerical rating scale (after 6 months).

Result(s)

A marked reduction in chronic pelvic pain was observed with both the prolonged cyclical and continuous treatment regimens (mean ± standard deviation change from baseline –3.3 ± 2.2 and –3.0 ± 2.2, respectively), with no significant difference between the two groups. With both regimens, patients experienced significant improvements in the intensity of chronic pelvic pain, number of days in which analgesics were required, severity of dysmenorrhea, sexual well-being, and health-related quality-of-life parameters. A favorable safety profile of dydrogesterone was confirmed, and no serious adverse drug reactions were reported during the study.

Conclusion(s)

Prolonged cyclical and continuous treatment regimens of dydrogesterone therapy both demonstrated a pronounced and similar reduction in the severity of chronic pelvic pain and dysmenorrhea and led to marked improvements in all study parameters related to quality of life and sexual well-being.

Registration Number

NCT03690765.

Los regímenes de tratamiento de didrogesterona cíclicos y continuos prolongados son efectivos para reducir el dolor pélvico crónico en mujeres con endometriosis: resultados del estudio ORCHIDEA.

Objetivo

Comparar la efectividad de dos regímenes de tratamiento diferentes de didrogesterona en el manejo de dolor pélvico crónico relacionado con la endometriosis.

Diseño

Estudio de cohortes prospectivo observacional durante seis meses.

Entorno

Veinte clínicas ginecológicas en la Federación Rusa.

Paciente(s)

Trescientas cincuenta mujeres entre 18 y 45 años de edad con endometriosis y dolor pélvico crónico con o sin dismenorrea.

Intervención(es)

Didrogesterona 10 mg 2 ó 3 veces al día, bien entre los días 5 y 25 del ciclo menestrual (régimen de tratamiento cíclico prolongado) o ininterrumpido (régimen de tratamiento continuo). Para todas las pacientes se limitó al recogida de datos a los seis meses de tratamiento.

Medida(s) de resultado principal(es)

Intensidad del dolor pélvico crónico en una escala de puntuación numérica de 11 puntos (tras 6 meses).

Resultado(s)

Se observó una marcada reducción del dolor pélvico crónico tanto con el régimen cíclico prolongado como con el continuo (cambio de nivel basal medio ± desviación estándar -3,3 ± 2,2 y -3,0 ± 2,2, respectivamente), sin diferencia significativa entre ambos grupos. Con ambos regímenes, las pacientes experimentaron mejoras significativas en intensidad del dolor pélvico crónico, número de días en que se requirieron analgésicos, severidad de la dismenorrea, bienestar sexual y parámetros de calidad de vida relacionados con la salud. Se confirmó un perfil de seguridad favorable de la didrogesterona, y no se informó de reacciones adversas severas a la medicación durante el estudio.

Conclusión(es)

Los regímenes de tratamiento prolongados cíclico y continuo de didrogesterona demostraron una reducción pronunciada y similar en la severidad del dolor pélvico crónico y la dismenorrea y resultaron en marcadas mejoras en todos los parámetros estudiados relacionados con calidad de vida y bienestar sexual.

Key Words

Dydrogesterone
dysmenorrhea
endometriosis
pelvic pain
progestogens

Cited by (0)

G.T.S. has nothing to disclose. L.V.A. has nothing to disclose. S.O.D. reports personal fees from Abbott, during the conduct of the study. I.I.B. has nothing to disclose. V.F.B. reports personal fees from Abbott, during the conduct of the study. A.V.K. reports personal fees from Abbott, during the conduct of the study. V.E.R. has nothing to disclose. M.R.O. reports personal fees from Abbott, during the conduct of the study. M.I.Y. reports personal fees from Abbott, during the conduct of the study. J.I.O. is an employee of Abbott Products Operations AG, Allschwil, Switzerland . S.O.D., V.F.B. Abbott made payment to Alpharmaxim Healthcare Communications for scientific writing.

This study was funded by Abbott Laboratories, Russia.