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

Contraceptive Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365426
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Universidad Vina del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• Diffuse Noxious Inhibitory Control

Intervention

Device:
• Mechanical stimulus
Electrical dynamometer to measure mechanical pressure

Procedure:
• Thermal (cold) stimulus
Water cold bath

Other:
• Oral contraceptive (OC)
Oral contraceptive (OC)
• No oral contraceptive (No OC)
No oral contraceptive (No OC)

Locations

Country	Name	City	State
Chile	Universidad Viña del Mar	Viña Del Mar	Valparaiso

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Vina del Mar

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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