A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03274297

2017-002186-22 (EudraCT Number)

CR108360

RWJ10553CON4001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component, as compared to the currently marketed EVRA patch.

Enrollment: 70 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 to exceed 100 kilogram
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This will be documented and signed by the investigator in the source document
• Participant must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy tests on Day -1 of each treatment period
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (example [eg], intrauterine device [IUD], double barrier method, male partner sterilization) before admission and throughout the study

Exclusion criteria

• Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, cholelithiasis (gall stone disease), chronic idiopathic jaundice, family history of cholestatic jaundice, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• 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 clinically significant abnormal 12-lead ECG, vital signs, or physical examination at screening as deemed appropriate by the investigator
• Participant has a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to, the following: a) Deep vein thrombophlebitis or thromboembolic disorders; b) Cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines; c) Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products; d) Known or suspected estrogen-dependent neoplasia

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

70 participants in 4 patient groups

Group 1: Sequence AB (Right/Left)

Experimental group

Description:

A single patch of currently marketed EVRA patch (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 the newly sourced adhesive component HMW PIB (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: 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: 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: 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: HMW PIB patch (NGMN+EE) (Treatment B) (Test)

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