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Treatment Choice in Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT03124524
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gulsum Uysal, Adana Numune Training and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Drug: estradiol valerate/dienogest Drug: ethinylestradiol and drospirenone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124524


Sponsors and Collaborators
Adana Numune Training and Research Hospital
Investigators
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Principal Investigator: Gulsum Uysal, M.D Adana Numune Training and Research Hospital

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Responsible Party: Gulsum Uysal, Principal Investigator, MD., Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03124524     History of Changes
Other Study ID Numbers: 2014/290
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: if needed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gulsum Uysal, Adana Numune Training and Research Hospital:
estradiol valerate/dienogest
ethinylestradiol/ drospirenone
pelvic pain
primary dysmenorrhea
uterine artery doppler indices

Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Nandrolone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Dienogest
Drospirenone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Contraceptive Agents, Male
Contraceptives, Oral
Antineoplastic Agents, Hormonal