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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04365426
Enrollment
50
Registered
2020-04-28
Start date
2020-04-24
Completion date
2021-08-30
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage, Diffuse Noxious Inhibitory Control

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.

Detailed 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.

Interventions

DEVICEMechanical stimulus

Electrical dynamometer to measure mechanical pressure

PROCEDUREThermal (cold) stimulus

Water cold bath

Oral contraceptive (OC)

OTHERNo oral contraceptive (No OC)

No oral contraceptive (No OC)

Sponsors

Universidad Vina del Mar
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy womenBaseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual periodThe 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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026