Treatment Choice in Primary Dysmenorrhea
|ClinicalTrials.gov Identifier: NCT03124524|
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Dysmenorrhea||Drug: estradiol valerate/dienogest Drug: ethinylestradiol and drospirenone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?|
|Actual Study Start Date :||January 15, 2015|
|Actual Primary Completion Date :||September 20, 2016|
|Actual Study Completion Date :||October 10, 2016|
No Intervention: Control group
33 healthy controls
Active Comparator: Qlarista Group
group who were administered estradiol valerate/dienogest
Drug: estradiol valerate/dienogest
oral, 28 tablets including 2 tablets of 3mg estradiol valerate, 5 tablets of 2mg estradiol valerate plus 2mg dienogest, 17 tablets of 2mg estradiol valerate plus 3mg dienogest, 2 tablets of 1mg estradiol valerate and 2 non hormonal tablets as placebo, respectively
Other Name: Qlarista; Bayer HealthCare Berlin, Germany
Active Comparator: Yasmin Group
group who were administered ethinylestradiol and drospirenone
Drug: ethinylestradiol and drospirenone
oral,0.03 mg ethinylestradiol and 3 mg drospirenone (21 tablets)
Other Name: Yasmin; Bayer HealthCare Berlin, Germany
- Doppler indices of uterine artery blood flows. [ Time Frame: up to 10 minutes ]Before and treatment during menstruation period the uterine artery blood flows were measured at the lateral level of uterine artery neighbour to cervicocorporeal junction in both sides (right and left). Doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels.
- Questionnaire Questionarie: Pain relief by using Visual analog scale (VAS) before and after treatment. [ Time Frame: up to 10 minutes ]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 and PD accompanied with vomiting, nausea, dizziness, headache, nervousness, diarrhea and fatigue were classified as severe PD. The ages (years), BMI (kg/m2), length of menstrual cycle (days) and lenght of bleeding (days) and demographic data of patients were recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124524
|Principal Investigator:||Gulsum Uysal, M.D||Adana Numune Training and Research Hospital|