Contraceptive UsageNCT04365426
Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women
A study testing Mechanical stimulus, Thermal (cold) stimulus and Oral contraceptive (OC) in people with Contraceptive Usage and Diffuse Noxious Inhibitory Control, run by Universidad Vina del Mar at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Diffuse Noxious Inhibitory Control
- What is being tested?
- Mechanical stimulus, Thermal (cold) stimulus and Oral contraceptive (OC)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 24 Apr 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
- Regular use of benzodiazepines.
- Systemic pathologies
- Pregnant women
- Menopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (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.
Read the 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.
- Being tested
- Mechanical stimulus, Thermal (cold) stimulus, Oral contraceptive (OC), No oral contraceptive (No OC)
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical stimulusDevice
Electrical dynamometer to measure mechanical pressure
Thermal (cold) stimulusProcedure or surgery
Water cold bath
Oral contraceptive (OC)Other
Oral contraceptive (OC)
No oral contraceptive (No OC)Other
No oral contraceptive (No OC)
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptive (OC) | Experimental | Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus. Receives: Device: Mechanical stimulus; Procedure: Thermal (cold) stimulus; Other: 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. Receives: Device: Mechanical stimulus; Procedure: Thermal (cold) stimulus; Other: No oral contraceptive (No OC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start24 Apr 2020
- Primary completion30 Jan 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Vina del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Pinto Pardo, Universidad Vina del Mar
- Investigators
- Nicolás Pinto-Pardo, DDS, Ms, Ph.D, Principal investigator, Universidad Vina del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365426
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (DNIC) in Non-painful Healthy Women
- ClinicalTrials.gov ID
- NCT04365426
- Acronym / sponsor ID
- 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Vina del MarUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptive (OC) | Experimental | Device: Mechanical stimulus, Procedure: Thermal (cold) stimulus, Other: Oral contraceptive (OC)Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus. |
| No oral contraceptive (No OC) | Experimental | Device: Mechanical stimulus, Procedure: Thermal (cold) stimulus, Other: No oral contraceptive (No OC)No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
- Regular use of benzodiazepines.
- Systemic pathologies
- Pregnant women
- Menopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical stimulusElectrical dynamometer to measure mechanical pressure | Device | No oral contraceptive (No OC), Oral contraceptive (OC) |
| Thermal (cold) stimulusWater cold bath | Procedure or surgery | No oral contraceptive (No OC), Oral contraceptive (OC) |
| Oral contraceptive (OC)Oral contraceptive (OC) | Other | Oral contraceptive (OC) |
| No oral contraceptive (No OC)No oral contraceptive (No OC) | Other | No oral contraceptive (No OC) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolás Pinto-Pardo, DDS, Ms, Ph.D principal investigator
Universidad Vina del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical stimulus, Thermal (cold) stimulus and Oral contraceptive (OC) in people with Contraceptive Usage and Diffuse Noxious Inhibitory Control, run by Universidad Vina del Mar at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.