Page last updated: 2024-11-02

oxybutynin and Pregnancy, Ectopic

oxybutynin has been researched along with Pregnancy, Ectopic in 1 studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

Pregnancy, Ectopic: A potentially life-threatening condition in which EMBRYO IMPLANTATION occurs outside the cavity of the UTERUS. Most ectopic pregnancies (

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's1 (100.00)2.80

Authors

AuthorsStudies
Schultheis, P1
Montoya, MN1
Zhao, Q1
Archer, J1
Madden, T1
Peipert, JF1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associa[NCT00635492]2,515 participants (Actual)Observational2008-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Changes in HbA1c From Baseline to Month 24

Changes in HbA1c From Baseline to Month 24 (NCT00635492)
Timeframe: Baseline, Month 24

Interventionpercentage of total hemoglobin (Mean)
Exenatide BID-1.03
Insulin-1.71

Changes in Weight From Baseline to Month 24

Changes in Weight From Baseline to Month 24 (NCT00635492)
Timeframe: Baseline, Month 24

Interventionkg (Mean)
Exenatide BID-3.22
Insulin2.16

Disinhibited Eating Associated With Treatment Choice at Baseline

Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Exenatide BID43.52
Insulin34.38

Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline

Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: 4 weeks prior to Baseline

Interventiontests/week (Mean)
Exenatide BID9.28
Insulin9.91

Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionkg/m^2 (Mean)
Exenatide BID35.3
Insulin29.7

Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline

Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher. (NCT00635492)
Timeframe: Baseline

Interventionpercent of hemoglobin (Mean)
Exenatide BID8.4
Insulin9.2

Higher Random Glucose Associated With Treatment Choice at Baseline

Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: 6 months prior to Baseline

Interventionmmol/L (Mean)
Exenatide BID10.37
Insulin12.13

Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline

Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionmmol/L (Mean)
Exenatide BID2.82
Insulin3.00

Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months

Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

Interventionpercentage of patients (Number)
Exenatide BID29.4
Insulin5.0

Incidence of Hypoglycemia Between Baseline and 24 Months

Incidence of Hypoglycemia between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

Interventionpercentage of patients (Number)
Exenatide BID17.5
Insulin35.2

Older Age Associated With Treatment Choice at Baseline

Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

Interventionyears (Mean)
Exenatide BID58.1
Insulin63.7

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis. (NCT00635492)
Timeframe: Month 24

Interventionpercentage of patients (Number)
Exenatide BID12.5
Insulin10.7

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis (NCT00635492)
Timeframe: Month 24

Interventionpercentage of patients (Number)
Exenatide BID26.9
Insulin28.5

Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline

Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). (NCT00635492)
Timeframe: Baseline

,
Interventionparticipants (Number)
MissingNoYesUnknown
Exenatide BID12131910124
Insulin1237905172

Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.

"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.~Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.~Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:~Insulin:~Addition of a new medication for the treatment of type 2 diabetes~A change in the number of times insulin is administered per day~Discontinuation of any insulin initiated at baseline~Substitution of a human insulin for an analogue insulin or vice-versa.~Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.~Exenatide:~Addition of a new medication for the treatment of type 2 diabetes~Discontinuation of exenatide." (NCT00635492)
Timeframe: Month 24

,
Interventionprobability (%) (Number)
Estimate at 24 monthsEstimate at 12 months
Exenatide BID53.967.8
Insulin60.670.6

Factors Associated With Treatment Change in Exenatide BID Cohort

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998). (NCT00635492)
Timeframe: Baseline to Month 24

Interventionhazard ratio (Number)
Gastro intestinal symptoms: yes vs no at baselineEQ-5D index value at baseline
Exenatide BID1.4630.601

Factors Associated With Treatment Change in Insulin Cohort

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort (NCT00635492)
Timeframe: Baseline to Month 24

Interventionhazard ratio (Number)
HbA1c (%) at baselineDHP barriers to activity subscale at baselineGastrointestinal symptoms: yes vs. no at baselineInsulin regimen: basal/bolus vs. long-acting onlyInsulin regimen: mixtures vs. long-acting onlyInsulin regimen: other vs. long-acting onlyInsulin regimen: short-acting only vs. long-actin
Insulin Cohort1.1180.9602.5320.4370.6760.5492.164

Number of Contacts With Health Care Providers Between Baseline and 24 Months

Number of contacts with Health Care Providers Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionnumber of contacts (Mean)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID7.1719.00
Insulin7.6424.58

Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months

Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionpercentage of patients (Number)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID94.490.4
Insulin94.192.3

Percentage of Patients Hospitalized Between Baseline and 24 Months

Percentage of Patients Hospitalized Between Baseline and 24 Months (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionpercentage of patients (Number)
Last 6 months prior to baselineBaseline to 24 months
Exenatide BID4.74.3
Insulin6.47.8

Reasons for Discontinuation of Baseline Regimen

Reasons for Discontinuation of Baseline Regimen (NCT00635492)
Timeframe: Baseline to Month 24

,
Interventionnumber of patients (Number)
Inadequate responseAdverse eventPatient decisionNon complianceCannot afford medicationOther
Exenatide BID17091699450
Insulin8711153138

Other Studies

1 other study available for oxybutynin and Pregnancy, Ectopic

ArticleYear
Contraception and ectopic pregnancy risk: a prospective observational analysis.
    American journal of obstetrics and gynecology, 2021, Volume: 224, Issue:2

    Topics: Cohort Studies; Contraceptive Agents, Female; Contraceptive Devices, Female; Contraceptives, Oral; D

2021