crossover randomized trial

NCT00254800

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Other conditions NCT00254800S000296

Design

Randomized: 32
Start year: 2005
Treatment: 12 weeks
Countries: United Kingdom (1 sites)
Sponsor: Amylin Pharmaceuticals and Eli Lilly (industry)
Eligibility: healthy premenopausal women 18 to 45 on oral contraceptives; BMI 19 to 35

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: other
Missing data

Arms

Arm	Treatment	Background	Randomized
A1	Standard care or no added treatment Oral contraceptive alone	ethinyl estradiol 30 ug and levonorgestrel 150 ug once daily; lifestyle: none	32
A2	Exenatide 10 ug subcutaneous twice daily Oral contraceptive 1 hour before exenatide	ethinyl estradiol 30 ug and levonorgestrel 150 ug once daily; lifestyle: none	32
A3	Exenatide 10 ug subcutaneous twice daily Oral contraceptive 30 minutes after exenatide	ethinyl estradiol 30 ug and levonorgestrel 150 ug once daily; lifestyle: none	32

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Whole trial ALL
age	mean (years)	28
age	sd (years)	6.8
bmi	mean (kg/m2)	25.1
bmi	sd (kg/m2)	3.2
female	percent	100
other smoker	n	12
weight	mean (kg)	69.0
weight	sd (kg)	9.3
white	n	31

Results

2 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events	58				not stated; other; R0026703:Results
	A3	events	74				not stated; other; R0026703:Results