Overview
Treatment Choice in Primary Dysmenorrhea
Status:
Completed
Completed
Trial end date:
2016-10-10
2016-10-10
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Adana Numune Training and Research HospitalTreatments:
Dienogest
Drospirenone
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Nandrolone
Polyestradiol phosphate
Criteria
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.