NCT04365426

Brief Summary

The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

April 24, 2020

Last Update Submit

September 27, 2021

Conditions

Contraceptive UsageDiffuse Noxious Inhibitory Control

Outcome Measures

Primary Outcomes (1)

  • Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women

    The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a mechanical pressure in the masseter (cephalic) and finger (extracephalic) stimulus as the "test stimulus" and a cold-water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.

    Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period

Study Arms (2)

Oral contraceptive (OC)

EXPERIMENTAL

Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.

Device: Mechanical stimulusProcedure: Thermal (cold) stimulusOther: Oral contraceptive (OC)

No oral contraceptive (No OC)

EXPERIMENTAL

No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.

Device: Mechanical stimulusProcedure: Thermal (cold) stimulusOther: No oral contraceptive (No OC)

Interventions

Mechanical stimulusDEVICE

Electrical dynamometer to measure mechanical pressure

No oral contraceptive (No OC)Oral contraceptive (OC)
Thermal (cold) stimulusPROCEDURE

Water cold bath

No oral contraceptive (No OC)Oral contraceptive (OC)
Oral contraceptive (OC)OTHER

Oral contraceptive (OC)

Oral contraceptive (OC)
No oral contraceptive (No OC)OTHER

No oral contraceptive (No OC)

No oral contraceptive (No OC)

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old.
  • Healthy women without oral contraceptive treatment, greater than or equal to 15 years old.
  • Non pregnant women.
  • Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
  • Without systemic pathologies.

You may not qualify if:

  • Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
  • Regular use of benzodiazepines.
  • Systemic pathologies
  • Pregnant women
  • Menopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Viña del Mar

Viña del Mar, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Cold TemperatureContraceptives, Oral

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Nicolás Pinto-Pardo, DDS, Ms, Ph.D

    Universidad Vina del Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Msc, Ph.D

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

April 24, 2020

Primary Completion

January 30, 2021

Study Completion

August 30, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)