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ABSTRACT: This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. Presumed ovulation (serum progesterone levels >or=3 ng/mL during Days 19-21 of Cycle 3), occurred in 0/41 (0%) subjects on ORTHO TRI-CYCLEN Lo and 3/43 (7%) subjects on ORTHO TRI-CYCLEN. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. The mean number of days of BBS/cycle for ORTHO TRI-CYCLEN Lo and ORTHO TRI-CYCLEN was 3.7 and 3.1, respectively, for those subjects with such bleeding. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.
Contraception 06/2003; 67(6):431-7. · 2.72 Impact Factor
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ABSTRACT: The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated.
In this randomized study, 610 subjects received 10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week.
The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P <.001). All regimens had safety profiles typical of oral contraceptives.
The 20-cm(2) patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance.
American Journal of Obstetrics and Gynecology 02/2002; 186(1):15-20. · 3.47 Impact Factor
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ABSTRACT: Context
Oral contraceptive (OC) pills are effective, but poor compliance increases
rates of pregnancy during treatment.Objective
To compare the contraceptive efficacy, cycle control, compliance, and
safety of a transdermal contraceptive patch and an OC.Design
Randomized, open-label, parallel-group trial conducted October 1997
to June 1999.Setting
Forty-five clinics in the United States and Canada.Participants
A total of 1417 healthy adult women of child-bearing potential.Interventions
Participants were randomly assigned to receive a transdermal contraceptive
patch (n = 812) vs an OC (n = 605) for 6 or 13 cycles. Patch treatment consisted
of application of 3 consecutive 7-day patches followed by 1 patch-free week.Main Outcome Measures
Overall and method-failure Pearl Indexes (number of pregnancies/100
person-years of use) and life-table estimates of the probability of pregnancy
were calculated. Cycle control, compliance, patch adhesion, and adverse events
were also assessed.Results
Overall and method-failure Pearl Indexes were numerically lower with
the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively);
this difference was not statistically significant (P
= .57 and .80, respectively). The incidence of breakthrough bleeding and/or
spotting was significantly higher only in the first 2 cycles in the patch
group, but the incidence of breakthrough bleeding alone was comparable between
treatments in all cycles. The mean proportion of participants' cycles with
perfect compliance was 88.2% (811 total participants, 5141 total cycles) with
the patch and 77.7% (605 total participants, 4134 total cycles) with the OC
(P < .001). Only 1.8% (300/16 673) of patches
completely detached. Both treatments were similarly well tolerated; however,
application site reactions, breast discomfort, and dysmenorrhea were significantly
more common in the patch group.Conclusion
The contraceptive patch is comparable to a combination OC in contraceptive
efficacy and cycle control. Compliance was better with the weekly contraceptive
patch than with the OC.
Figures in this Article
Worldwide more than 100 million women choose hormonal contraception
for family planning,1 with more than 12 million
users in the United States alone.2- 3
Combined oral contraceptives (OCs) are widely used because of the efficacy
demonstrated in clinical trials and the established safety from postmarketing
surveillance.4 However, while clinical trials
have shown that correct and consistent use of OCs results in a first-year
failure rate of 0.1%,5 the 1995 National Survey
of Family Growth (US data) estimated that actual first-year failure rates
during typical use of OCs range from 7.3% to as high as 8.5%.6
Noncompliance is the primary reason cited to explain this difference.7- 9 There is clearly a need
for reversible contraceptives with a more convenient dosing schedule that
would enhance patient compliance and achieve high contraceptive efficacy in
typical use.
The transdermal contraceptive patch has been evaluated as a new method
of contraception in several trials. Pharmacokinetic data from studies involving
the contraceptive patch, which delivers 150 µg of norelgestromin and
20 µg of ethinyl estradiol daily to the systemic circulation,10 have been published.11- 14
This study is the first published clinical trial of transdermal contraception.
The objective of this study was to compare the transdermal contraceptive patch
and an OC in terms of contraceptive efficacy, cycle control, compliance, and
safety. The a priori hypotheses were that the contraceptive patch would be
comparable to the OC with respect to contraceptive efficacy, cycle control,
and safety but better than the OC with respect to compliance.
JAMA The Journal of the American Medical Association 285(18):2347-2354. · 30.03 Impact Factor
