Birth Control Pill vs Birth Control Patch Study

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study was a randomized, investigator-blinded, cross-over, clinic trial using twenty-four healthy women aged 18-35. All women received two months of the birth control patch or birth control pill, two months without any drug, then two months of the alternative drug. The birth control patch contained 0.75 milligrams ethinyl estradiol and 6 milligrams norelgestromin. The birth control pill contained 35 micrograms ethinyl estradiol and 250 micrograms norgestimate. Blood samples were taken before and after each treatment and were analyzed for the following lab values: D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein and normalized activated protein C sensitivity ratio (nAPCsr). Two thrombin generation-based assays were used: the α2macroglobulin-thrombin endpoint method (α2M-IIa) and calibrated automated thrombinography (CAT).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Vermont
• Collaborator: University of Vermont Medical Center
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norelgestromin; Norgestimate; Ortho Evra; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Women ages 18-35 years of age

• Not on hormones for at least 2 months prior to enrollment

• Must be more than 3 months post-partum, &

• Generally healthy.

Exclusion Criteria:

• Women with prior history of contraindications to taking birth control pills

• History of Deep Vein Thrombosis or Pulmonary Embolism

• Known history of coagulation disorders

• Liver disease

• Pregnant or actively attempting pregnancy

• Currently breastfeeding

• Uncontrolled hypertension

• Migraines with ischemic changes, &

• Weight more than 199 lbs.