Clinical trial NCT00236782: A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.
Official title: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17dNorgestimate and Ethinyl Estradiol With the Oral Contraceptive Mercilon.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: contraception
hormonal contraception
oral contraception
steroid, ethinyl estradiol, progestin contraception
transdermal.
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 1517
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Mercilon.

Detailed description: This is an open-label, multicenter, international study to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared with Mercilon. Fourteen hundred healthy women will receive study medication for either 6 or 13 cycles. The first 265 transdermal patch subjects and the first 200 Mercilon subjects will be expected to complete 13 cycles of medication. All subsequent subjects will be expected to complete 6 cycles. The ratio of subjects assigned to the transdermal patch arm of the study and to the Mercilon arm will be 4:3. At admission (Visit 1) study drug, diary cards and subject instructions for Cycle 1 and replacement patches for Cycles 1 to 6 are dispensed. The first patch will be applied and Mercilon pill will be taken on the first day of menses. Study medication and diary cards will be issued on day 28 of Cycles 1 (Visit 2) and 3 (Visit 3), and those continuing for 13 cycles will receive study drug again on day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication packages will be collected at every visit. Final visits are on day 28 of Cycles 6 and 9. Diary card information was used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations were based on adverse events, which were collected throughout the study, and changes in gynecologic examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks.The fourth week is patch-free. A Mercilon pill is taken for 21 consecutive days followed by a 7-day pill-free week.

Eligibility criteria: Inclusion Criteria:

* Healthy women with regular menstrual cycles
* sexually active and at risk of pregnancy
* nonpregnant
* acceptable body mass index (BMI)
* last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
* sitting BP\<140mmHg/\<90mmHg
* 1 normal menstrual cycle since removal of IUD or norplant
* agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
* agree not to use other systemic steroid medication
* signed Informed Consent Form.

Exclusion Criteria:

* Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
* cerebral vascular or coronary artery disease, hypertension, or severe migraines
* liver tumor resulting from estrogen-containing products
* diabetes mellitus
* cholestatic jaundice, liver or renal disease
* neurovascular lesion of the eye or serious visual disturbance
* abnormal PAP smear
* undiagnosed abnormal vaginal bleeding
* thyroid disorder
* dermal hypersensitivity
* carcinoma of breast, endometrium or other estrogen-dependent neoplasia
* substance abuse
* received experimental drug or any hepatic enzyme-inducing drugs within prior 30 days
* received any depot hormone injection within prior 6 months
* smoking women over 35 years of age.

Primary outcomes:
measure: Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.
Secondary outcomes:
measure: Cycle control and compliance were assessed with diary cards containing bleeding and dosing information.
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002 Feb;77(2 Suppl 2):S13-8. doi: 10.1016/s0015-0282(01)03275-7.
citation: Zacur HA, Hedon B, Mansour D, Shangold GA, Fisher AC, Creasy GW. Integrated summary of Ortho Evra/Evra contraceptive patch adhesion in varied climates and conditions. Fertil Steril. 2002 Feb;77(2 Suppl 2):S32-5. doi: 10.1016/s0015-0282(01)03262-9.