Female contraceptive MedDRA version: 13.1 Level: HLT Classification code 10010812 Term: Contraceptive methods female System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: AG200-15
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Agile Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sexually active women requesting contraception; 2. 18 to 40 years old; 3. Regular menses every 21 - 35 days; if current continuous use of hormonal birth control historical data will be used to determine qualification. 4. Body Mass Index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected pregnancy; 2. Lactating women; 3. Breast-feeding within 42 days prior to the start of study medication; 4. Abnormal Papanicolaou (Pap) smear as noted in Appendix D (PAP smear results within last 6 months are acceptable if properly documented and meet the criteria noted in Appendix D ); 5. Women who smoke and are =35 years old or will turn 35 anytime during the study; 6. Uncontrolled hypertension (blood pressure =140 mm Hg systolic or =90 mm Hg diastolic); 7. Valvular heart disease with complications; 8. Diabetes Mellitus with vascular disease; 9. History of headaches with focal neurological symptoms; 10. Uncontrolled thyroid disorder; 11. Sickle cell anemia; 12. Current or history of clinically significant depression in the last year; 13. Known disturbance of lipid metabolism; triglycerides >3.4 mmol/l; 14. Acute or chronic hepatocellular disease with abnormal liver function; 15. Hepatic adenoma or carcinoma; 16. Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate AG200-15 with regard to contraceptive efficacy.;Secondary Objective: To evaluate AG200-15 with regard to cycle control (bleeding pattern), subject´s compliance and safety. Also evaluation of wearability (including adhesion).;Primary end point(s): Pregnancy rates;Timepoint(s) of evaluation of this end point: A urine pregnancy test is done at each visit and throughout the course of the study, the subject will perform urine pregnancy tests if no withdrawal bleeding occurs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety (adverse events), menstrual cycle control (bleeding pattern), patch replacement and subject's compliance, patch adherence and wearability, subject's satisfaction.;Timepoint(s) of evaluation of this end point: Continously throughout the course of the study. | — |
Countries
Denmark
Contacts
Public ContactClinical Research Organization
IRW Consulting AB
Outcome results
None listed