drugset / Trial / NCT03124524

Treatment Choice in Primary Dysmenorrhea

NCT03124524

Phase 4 Completed 99 enrolled Adana Numune Training and Research Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and ethinylestradiol/ drospirenone by using doppler indices. 100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels before treatment. The 66 PD patients who met the inclusion criteria were divided into 2 groups and 33 healthy controls created Group 1. Group 2 were administered estradiol valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment. The changes in values were recorded.

Timeline

Start
2015-01-15
Primary completion
2016-09-20
Completion
2016-10-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dienogest Small molecule 3 mg Oral
Comparator drospirenone Unknown 3 mg Oral
Comparator estradiol valerate Unknown 2 mg Oral
Comparator ethinyl estradiol Small molecule 0.03 mg Oral

Indications