Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control

NCT01250210 | Completed Phase 2 Results

• 1 other identifier: ATI-CL11
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 11

Brief Summary

Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).

Conditions

Ovulation Suppression

Keywords

contraception; pregnancy prevention

Outcome Measures

Primary Outcomes (2)

• Ovulation Suppression in Three Treatment Groups Over 3 Cycles

  Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are: Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points. Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points. Perfect compliance: If no patch has been off \>1 day and no more than 1 day has elapsed between patch changes. Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.

  3 months

• Cycle Control

  The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.

  3 months

Study Arms (3)

AG200-15

EXPERIMENTAL

Drug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol.

Drug: levonorgestrel and ethinyl estradiol

AG200

EXPERIMENTAL

Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol.

Drug: levonorgestrel and ethinyl estradiol

AG200LE

EXPERIMENTAL

Drug intervention with levonorgestrel and ethinyl estradiol: AG200LE a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.28 mg of ethinyl estradiol.

Drug: levonorgestrel and ethinyl estradiol

Interventions

levonorgestrel and ethinyl estradiol DRUG

pregnancy prevention

Also known as: contraception, hormonal contraception, transdermal

AG200; AG200-15; AG200LE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult women, ages 18-45.
• Cycles with a usual duration between 21 and 35 days and an individual variation of +/ 3 days.
• Normotensive (blood pressure \< 140/90 mm Hg at rest) at screening and randomization visits (Visits 1 and 2).
• Willing to use a non-hormonal method of contraception for the entire duration of the study, or
• Have already undergone previous bilateral tubal ligation OR vasectomized partner OR not at risk of pregnancy.
• Willing to refrain from excessive use of alcohol during the entire duration of the study.
• Willing to give informed consent to participate in the study.

You may not qualify if:

• History of significant medical illness or seizures.
• Positive hepatitis B or C antibody or positive human immunodeficiency virus (HIV) antibody.
• Known or suspected pregnancy.
• A recent abnormal cervical smear - low-grade squamous intraepithelial lesion (SIL) or higher in the Bethesda System - which has not been resolved or treated.
• Any disorder that contraindicates the use of contraceptive steroids i.e., history of heart attack and stroke, blood clots in the legs, lungs or eyes, history of blood clots in the deep veins of the legs, known or suspected breast cancer, hepatitis or yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, headaches with neurological symptoms, disease of heart valves with complications.
• Uncontrolled thyroid disorder.
• History of or existing thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease.
• Undiagnosed abnormal genital bleeding.
• Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia.
• History or presence of dermal hypersensitivity in response to topical application.
• Use of an injectable hormonal contraceptive (e.g. Depo-Provera®) within 6 months prior to Day 1.
• Use of a contraceptive implant (e.g. Implanon® or Jadelle®) or hormone-medicated intrauterine device within 2 months (60 days) prior to Day 1.
• Use of OCs or other sex steroid hormones within 60 days prior to Day 1.
• Women who are breast-feeding or are within 2 months of stopping breast-feeding.
• Status post-partum or post-abortion within a period of 2 months prior to Day 1.

Sponsors & Collaborators

• Agile Therapeutics: lead

Study Sites (11)

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Pembroke Pines, Florida, 33026, United States

Location

Unknown Facility

Tampa, Florida, 33607, United States

Location

Unknown Facility

Sandy Springs, Georgia, 30328, United States

Location

Unknown Facility

Cary, North Carolina, 27518, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Jenkintown, Pennsylvania, 19046, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19114, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination; Contraception; Hormonal Contraception; Administration, Cutaneous

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Administration, Topical; Drug Administration Routes; Drug Therapy

Results Point of Contact

• Title: Joseph Chiodo III, Senior Medical Director
• Organization: Agile Therapeutics

jachiodo@agiletherapeutics.com

609-683-1880

Study Officials

• Elizabeth Garner, MD, MPH

  Agile Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 5, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-07

Locations

US (11)