Clinical Trial: Treatment Choice in Primary Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?

Brief 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.

Detailed Summary:

This prospective, randomized, controlled clinical trial was conducted in Kayseri Education and Research Hospital, in Turkey between 2015 and 2016. Nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included to the study. Afterwards, based on computer generated random numbers the patients were allocated to one of the two study arms; Group2 (Qlarista group) and Group3 (yasmin group), equally.

The PD was diagnosed clinically. The characteristic of pain was periodic (at least following 3 menstrual cycles), midline, lower abdominal cramps or pelvic colic like pain that starts up to one day before menses, lasts for the 3 days of bleeding, gradually diminishes over 12 to 72 hours and ends after period. The pain starts generally in 2 to 3 years after menarche with regular menses (25-31 day). Also absence of pelvic pathology was important in these patients for diagnosis.

Patients with history of pelvic inflammatory diseases, endometriosis, ovarian cysts, chronic abdominal pain, fibroids, obstructive endometrial polyps, cervical stenosis, inflammatory bowel syndrome, irritable bowel syndrome, major abdominal or pelvic surgery, intrauterine device and congenital obstructive müllerian malformations were excluded. Smoking, overweighted (body mass index (BMI) ≥ 30) patients that oral contraceptive pills (OCP) treatment was contraindicated were also excluded. Additionally, patients enrolled simultaneously into other studies that require drug intake or otherwise prevent compliance with protocol were out of the study.

Visual analog scale (VAS) from 0 (no pain) to 10 (maximum pain, 'worst pain I have ever felt') was applied to patients on the first day of menstrual cycle. Patients with VAS score of between 7 to10 a
Sponsor: Adana Numune Training and Research Hospital

Current Primary Outcome: Doppler indices of uterine artery blood flows. [ Time Frame: up to 10 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Questionnaire Questionarie: Pain relief by using Visual analog scale (VAS) before and after treatment. [ Time Frame: up to 10 minutes ]

Original Secondary Outcome: Same as current

Information By: Adana Numune Training and Research Hospital

Dates:
Date Received: March 9, 2017
Date Started: January 15, 2015
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017