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NCT03124524

Treatment Choice in Primary Dysmenorrhea

Completed Phase 4 Last updated 26 April 2017
What this trial tests

Phase 4 trial testing estradiol valerate/dienogest in Primary Dysmenorrhea in 99 participants. Completed in 10 October 2016.

Timeline
15 January 2015
Primary endpoint
20 September 2016
10 October 2016

Quick facts

Lead sponsorAdana Numune Training and Research Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment99
Start date15 January 2015
Primary completion20 September 2016
Estimated completion10 October 2016

Drugs / interventions tested

Conditions studied

Sponsor

Adana Numune Training and Research Hospital

Who can join

Adults 18 to 35, female only, with Primary Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Combined oral contraceptive pill for primary dysmenorrhoea.
    Schroll JB, Black AY, Farquhar C, Chen I. · · 2023 · cited 16× · PMID 37523477 · DOI 10.1002/14651858.cd002120.pub4
  2. A comparison of two different oral contraceptives in patients with severe primary dysmenorrhoea.
    Uysal G, Akkaya H, Cagli F, Tutus S, et al · · 2018 · cited 12× · PMID 29537325 · DOI 10.1080/01443615.2017.1410533

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Other recruiting trials for Primary Dysmenorrhea

Currently open trials in the same condition.

Other Adana Numune Training and Research Hospital trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing