Insulin SensitivityPhase 4NCT01475513

Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

A Phase 4 study testing Ortho Cyclen® in people with Insulin Sensitivity and Cardiovascular Risk, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder
What is being tested?: Ortho Cyclen®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Nov 2011to 28 May 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Premenopausal, regular-cycling women 18-35 years
Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
non-smoker.

Who cannot join

Diabetes
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0111

Other trials in United States

About this study

Read the detailed description

The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.

Conditions: Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder
Being tested: Ortho Cyclen®
Keywords: oral contraceptive, birth control pill, women, healthy volunteer, insulin sensitivity, insulin resistance, cardiovascular risk factors, endothelial function, estrogen metabolism, racial difference, glucose intolerance
Medical subject headings: Insulin Resistance, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ortho Cyclen®Drug
Also called Orthocyclen, Sprintec, Previfem, MonoNessa
Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.

Study groups in NCT01475513
Study group	Role	What they receive
African-American women	Active comparator	African-American women Receives: Drug: Ortho Cyclen®
Caucasian women	Active comparator	Caucasian women Receives: Drug: Ortho Cyclen®

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Insulin Sensitivity
Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity
Measured: Baseline, 6 months
Change From Baseline in Flow-mediated Vasodilatation
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Measured: Baseline, 6 months
Change From Baseline in Carotid Intima Media Thickness
Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile
Measured: baseline, 6 months

Secondary outcomes (13)

Change From Baseline in Acute Insulin Response to Glucose
Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response
Measured: Baseline, 6 months
Change From Baseline in Glucose Effectiveness
Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Measured: Baseline, 6 months
Change From Baseline in Disposition Index at 6 Months
Modeled from FISVGTT--higher values indicate better glucose disposition
Measured: Baseline, 6 months
Change From Baseline in Fasting Insulin at 6 Months
Higher fasting insulin values indicate an increased metabolic risk
Measured: Baseline, 6 months
Change From Baseline in Fasting Glucose at 6 Months
Higher fasting glucose indicate an increased metabolic risk
Measured: Baseline, 6 months
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months
Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Measured: Baselines, 6 months
Change From Baseline in Areas-under-the-curve for Glucose
Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Measured: Baseline, 6 months
Change From Baseline in Systolic Blood Pressure at 6 Months
Higher value indicates increased cardiovascular risk
Measured: Baseline, 6 months
Change From Baseline in HDL at 6 Months
Lower values indicate increased cardiovascular risk
Measured: Baseline, 6 months
Change From Baseline in Body Mass Index in 6 Months
Higher values indicate higher metabolic risk
Measured: Baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months
Higher value indicates higher cardiovascular risk
Measured: Baseline, 6 months
Change in LDL From Baseline to 6 Months
Higher value indicates higher cardiovascular risk
Measured: Baseline, 6 months
Change in Triglycerides From Baseline to 6 Months
Higher values indicate higher cardiovascular risk
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201128 May 2014

First posted21 Nov 2011 (estimated)
Study startNov 2011
Primary completion28 May 2014
Study completion28 May 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Insulin SensitivityStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
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 4
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01475513
Sponsor's protocol ID: HM13769
Status last verified: Jul 2018
First submitted: 8 Nov 2011
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes

All Insulin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
ClinicalTrials.gov ID: NCT01475513
Acronym / sponsor ID: HM13769
Conditions: Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder
Keywords: oral contraceptive, birth control pill, women, healthy volunteer, insulin sensitivity, insulin resistance, cardiovascular risk factors, endothelial function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: American Heart Association
Study start: Nov 2011
Primary completion: 28 May 2014 (actual)
Study completion: 28 May 2014 (actual)
First posted: 21 Nov 2011 (estimated)
Results: Posted 10 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)

Arm	Type	Receives
African-American women	Active comparator	Drug: Ortho Cyclen®African-American women
Caucasian women	Active comparator	Drug: Ortho Cyclen®Caucasian women

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Premenopausal, regular-cycling women 18-35 years
Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
non-smoker.

Key exclusion criteria (4 listed)

Diabetes
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months

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
Ortho Cyclen®Also: Orthocyclen, Sprintec, Previfem, MonoNessaEthinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.	Drug	African-American women, Caucasian women

Primary outcome

Change From Baseline in Insulin Sensitivity
Time frame: Baseline, 6 months
Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity
Change From Baseline in Flow-mediated Vasodilatation
Time frame: Baseline, 6 months
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Change From Baseline in Carotid Intima Media Thickness
Time frame: baseline, 6 months
Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile

13 secondary outcomes

Change From Baseline in Acute Insulin Response to Glucose
Time frame: Baseline, 6 months
Change From Baseline in Glucose Effectiveness
Time frame: Baseline, 6 months
Change From Baseline in Disposition Index at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Fasting Insulin at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Fasting Glucose at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months
Time frame: Baselines, 6 months
Change From Baseline in Areas-under-the-curve for Glucose
Time frame: Baseline, 6 months
Change From Baseline in Systolic Blood Pressure at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in HDL at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Body Mass Index in 6 Months
Time frame: Baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months
Time frame: Baseline, 6 months
Change in LDL From Baseline to 6 Months
Time frame: Baseline, 6 months
Change in Triglycerides From Baseline to 6 Months
Time frame: Baseline, 6 months

Results and safety

Results posted to the registry on 10 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
African-American Women	20	17
Caucasian Women	26	16

Primary outcome: Change From Baseline in Insulin Sensitivity

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: min ^ -1 / mIU / L

Measure	African-American Women n = 16	Caucasian Women n = 15
Value	-1.91 (-5.63 to 1.80)	-5.63 (-9.47 to -1.80)

Primary outcome: Change From Baseline in Flow-mediated Vasodilatation

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: mm

Measure	African-American Women n = 5	Caucasian Women n = 9
Value	0.0503 (-0.0905 to 0.19099)	-0.0210 (-0.0868 to 0.04479)

Population analysed: Data based on images. Some participants images could not be analyzed numerically.

Primary outcome: Change From Baseline in Carotid Intima Media Thickness

Time frame: baseline, 6 months. Mean (95% Confidence Interval). Unit: mm

Measure	African-American Women n = 4	Caucasian Women n = 9
Value	-0.00008 (-0.0054 to 0.00523)	0.00118 (-0.0024 to 0.00472)

Population analysed: Data based on images. Some participants images could not be analyzed numerically.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Post-baseline follow-up phone call at 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
African-American Women	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Caucasian Women	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): Small numbers of subjects analyzed. Some subjects did not have reportable carotid intima media thickness and flow mediated dilatation values.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insulin Sensitivity

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes

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.

Kai Cheang, Pharm. D. principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ortho Cyclen® in people with Insulin Sensitivity and Cardiovascular Risk, run by Virginia Commonwealth University at 1 site in United States.

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 3 inclusion and 4 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 8 Aug 2018. 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Insulin Sensitivity (time frame: Baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01475513.

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 8 Aug 2018.