An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to document the experience of transdermal contraceptive patch over a period of 9 cycles, compared to their previous contraceptive method.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norelgestromin; Norgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy females, who were sexually active and at risk of pregnancy were eligible to participate in this study provided that they had regular menses occurring every 25 to 35 days (except for those women using medroxyprogesterone acetate)

• women who were using one of the following methods of contraception as their primary method in the 3 months prior to admission: oral contraceptive, intrauterine device, medroxyprogesterone acetate injection, double-barrier method consisting of condoms and spermicidal foam or gel, or a diaphragm and spermicidal foam or gel

• study participants had to have a normal Pap smear within the previous 12 months

• a negative urine pregnancy test at admission

• have a systolic/diastolic blood pressure <= 140/90 mm Hg

• be within 35% of acceptable body mass index (upper limit of 32.4)

• be willing to switch their current method of contraception

• and agree not to use any other steroid hormonal therapy other than topical corticosteroids or inhaled corticosteroids for asthma, during the course of the study.

Exclusion Criteria:

• History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, e.g., deep vein thrombophlebitis, thromboembolic disorders, cerebral vascular or coronary artery disease, etc.

• Additionally, participants who were menopausal

• had skin conditions resulting in oily, irritated or damaged skin at all potential application sites

• Had a history or presence of dermal hypersensitivity

• The presently used contraceptive method were any of condoms alone, abstinence, withdrawal, or a rhythm method

• Had received medroxyprogesterone acetate injection <=12 weeks prior to enrolment

• had a history of alcohol or substance abuse within 12 months of enrolment

• had received any experimental drug or device within 30 days of enrolment

• Had used barbiturates, antiepileptics, rifampin, griseofulvin, or other hepatic enzyme inducing drugs within 30 days of enrolment

• Chronic systemic antibiotic use

• Had an uncontrolled thyroid disorder

• Were smokers over the age of 35

• Had Pap smear evidence of atypical squamous cells or adenocarcinoma or other malignancy

• Had a desire to conceive in the subsequent 9 months of enrolment