A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04017195

CR108645

RWJ10553CON1019 (Other Identifier)

2019-001893-27 (EudraCT Number)

Details and patient eligibility

About

The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and body weight not less than 50 kilogram (kg) and not more than 100 kg at screening
• Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing a highly effective method (that is, failure rate of less than [<] 1 percent [%] per year) of non hormonal contraception (example, intrauterine device [IUD], male partner sterilization) before admission and throughout the study
• Participant has a blood pressure (after the participant is supine or sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
• Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: Normal sinus rhythm with heart rate between 45 and 100 beats per minute (bpm), extremes included; QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) =<470 millisecond (ms); QRS interval =<120 ms; PR interval =<220 ms. ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block and left or right bundle branch block is exclusionary
• Participant must be a non-smoker, ex-smoker for greater than (>) 6 months, must not use nicotine containing substances including tobacco products (example, cigarettes, e-cigarettes. cigars, chewing tobacco, gum, patch), or tests negative for cotinine at screening and on Day 1 of each treatment period

Exclusion criteria

• Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
• Participant has abnormal thyroid stimulating hormone level at screening
• Participant has evidence of cervical dysplasia as documented by a CytoRich test or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP smear has been done within 10 months prior to screening and results are available (documentation is available at the study site) a cervical smear does not need to be performed
• Participant has used oral hormonal contraception, that is, contraceptive pills, within 3 months before admission to the study site on Day -1 of Treatment Period 1
• Participant currently has a contraceptive implant such as Implanon or Norplant in place, or has had removal of contraceptive implant within the 3 months before admission to the study site on Day -1 of Treatment Period 1

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

68 participants in 4 patient groups

Group 1: Sequence AB (Right/Left)

Experimental group

Description:

A single patch of currently marketed EVRA patch using the adhesive component at the beginning of shelf life (BOSL) (Treatment A) will be applied to the right buttock of participants on Day 1 of Treatment Period 1, followed by application of a single patch of transdermal contraceptive using newly sourced adhesive component HMW PIB at the end of shelf life (EOSL) (Treatment B) to left buttock of participants on Day 1 of Treatment Period 2. The Treatment periods will be separated by a washout period of 21 days.

Treatment:

Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)

Group 2: Sequence BA (Right/Left)

Experimental group

Description:

Treatment B will be applied to the right buttock of participants on Day 1 in Period 1, followed by Treatment A to the left buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.

Treatment:

Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)

Group 3: Sequence AB (Left/Right)

Experimental group

Description:

Treatment A will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment B to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.

Treatment:

Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)

Group 4: Sequence BA (Left/Right)

Experimental group

Description:

Treatment B will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment A to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.

Treatment:

Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)