Treatment Choice in Primary Dysmenorrhea

NCT03124524 | Completed Phase 4 DMC

• 1 other identifier: 2014/290
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Dysmenorrhea

Keywords

estradiol valerate/dienogest; ethinylestradiol/ drospirenone; pelvic pain; primary dysmenorrhea; uterine artery doppler indices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Questionnaire Questionarie: Pain relief by using Visual analog scale (VAS) before and after treatment.

  up to 10 minutes

Study Arms (3)

Control group

NO INTERVENTION

33 healthy controls

Qlarista Group

ACTIVE COMPARATOR

group who were administered estradiol valerate/dienogest

Drug: estradiol valerate/dienogest

Yasmin Group

ACTIVE COMPARATOR

group who were administered ethinylestradiol and drospirenone

Drug: ethinylestradiol and drospirenone

Interventions

estradiol valerate/dienogest DRUG

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

Also known as: Qlarista; Bayer HealthCare Berlin, Germany

Qlarista Group

ethinylestradiol and drospirenone DRUG

oral,0.03 mg ethinylestradiol and 3 mg drospirenone (21 tablets)

Also known as: Yasmin; Bayer HealthCare Berlin, Germany

Yasmin Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adana Numune Training and Research Hospital: lead

MeSH Terms

Conditions

Pelvic Pain

Interventions

estradiol valerate-dienogest; Ethinyl Estradiol; drospirenone; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gulsum Uysal, M.D

  Adana Numune Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: April 24, 2017
• Study Start: January 15, 2015
• Primary Completion: September 20, 2016
• Study Completion: October 10, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share