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Completed

NCT Number: NCT04365426

Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women

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.

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Key information

Conditions

Contraceptive Usage Behavior Contraception Behavior Diffuse Noxious Inhibitory Control Reproductive Behavior

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Viña del Mar

Viña del Mar, Valparaiso, Chile

About this study

After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Mechanical stimulus

Device

Electrical dynamometer to measure mechanical pressure

Thermal (cold) stimulus

Procedure

Water cold bath

Oral contraceptive (OC)

Other

Oral contraceptive (OC)

No oral contraceptive (No OC)

Other

No oral contraceptive (No OC)

Primary outcomes

  1. Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women

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

    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.

Sponsors and collaborators

Lead sponsor

Universidad Vina del Mar

Other

Registry information

Official study title

Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (DNIC) in Non-painful Healthy Women

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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