Primary Dysmenorrhea Clinical Trial
Official title:
Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?
Verified date | April 2017 |
Source | Adana Numune Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | October 10, 2016 |
Est. primary completion date | September 20, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - must be nullipara patients with symptoms of severe primary dysmenorrhea. - The characteristic of pain must be 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, - ends after period. - The pain must start generally in 2 to 3 years after menarche with regular menses (25-31 day). Exclusion Criteria: - 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, - congenital obstructive müllerian malformations. - patients that OCP treatment was contraindicated - patients enrolled simultaneously into other studies that require drug intake or otherwise prevent compliance with protocol. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Adana Numune Training and Research Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Doppler indices of uterine artery blood flows. | 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. | up to 10 minutes | |
Secondary | Questionnaire Questionarie: Pain relief by using Visual analog scale (VAS) before and after treatment. | 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. | up to 10 minutes |
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