A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process); Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02127593

2014-000983-16 (EudraCT Number)

10131CON1001 (Other Identifier)

CR104172

Details and patient eligibility

About

The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by dry process, in healthy women.

Full description

This is a Phase 1, single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), randomized (the study medication is assigned by chance), single-center and a 2-way crossover (method used to switch participants from one study group to another in a clinical trial) study in healthy women. The study consists of 3 parts: Screening phase, Treatment phase and end-of-study or withdrawal. Treatment periods will be separated by a wash out period of at least 10 days. The duration of participation in the study for an individual participant will be approximately 7 weeks. All participants will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences and receive both of the following treatments: 1 oral tablet formulated by wet process or dry process, whereas each tablet contains norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg. The primary endpoint of the study will be assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be either surgically sterile or of child-bearing potential and be practicing an effective non-hormonal method of birth control (for example, copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
• If a woman of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of the each treatment period
• Participants must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last dose
• Body mass index (BMI: weight [kilogram {kg}]/height^2 [meter {m}]^2) between 18.5 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg) or higher than 90 kg (198 pounds)
• Participant must be a non-smoker

Exclusion criteria

• Participants have a levonorgestrel implant (for example, Norplant) in place or removed within the 30 days before admission to the study site
• Contraindications to combined hormonal contraceptives
• Participants who received medroxyprogesterone injection (for example, Depo Provera) within 6 months of admission to the study
• Use of any other hormonal contraceptive within 30 days of admission to the study site
• Participants with abnormal papanicolaou (Pap) smear or CytoRich test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

101 participants in 2 patient groups

First NGM/EE (Wet Process), then NGM/EE (Dry Process)

Experimental group

Description:

Participants will receive 1 tablet (formulated by wet process) containing norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.

Treatment:

Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)

Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)

First NGM/EE (Dry Process), then NGM/EE (Wet Process)

Experimental group

Description:

Participants will receive 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by wet process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.

Treatment:

Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)

Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)