Evaluation of a hormone and NSAID on ovarian function in healthy female volunteers Pregnancy and Childbirth
Conditions
Interventions
3-period, randomized, cross-over trial (Part 1), followed by a pharmacokinetics assessment of the a combined product in a subset of participants (Part 2)
Intervention 1: One-time oral dose of a single
Sponsors
FHI 360
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Is 18 to 40 years of age (inclusive) 2. Is in good general health based on results of physical examination, medical history and vital signs tests 3. Is able and willing to provide informed consent and follow all trial requirements 4. Has regular menstrual cycles (24-35 days) 5. Has ovulatory cycle during the screening 6. Has had tubal ligation 7. Has a body mass index of 18.0-35.0 (kg/m2) 8. Has hemoglobin =10.0 g/dl
Exclusion criteria
Exclusion criteria: 1. Recently (within the last 3 months) or currently pregnant 2. Is currently lactating 3. Has more than one risk factor for cardiovascular disease (such as smoking, diabetes, hypertension, and known dyslipidemias) 4. Has hypertension with systolic blood pressure =160 mmhg, and/or diastolic blood pressure =100 mmhg 5. Has hypertension with vascular disease 6. Has a history of coronary artery bypass graft (CABG) surgery 7. Currently has and/or has a history of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or a hereditary or acquired predisposition or elevated risk for venous thrombosis 8. Currently has or has a history of ATE (myocardial infarction, stroke, or peripheral arterial disease) or a hereditary or acquired predisposition or elevated risk for arterial thrombosis 9. Has a history of cerebrovascular bleeding, gastrointestinal bleeding, or other bleeding disorders 10. Has systemic lupus erythematosus 11. Has migraine with aura 12. Has unexplained vaginal bleeding 13. Has undiagnosed mass in the breast 14. Currently has and/or has a history of breast cancer 15. Currently has cervical cancer (including CIN 3) 16. Has known hypersensitivity to hormonal medications 17. Has known hypersensitivity to non-steroidal anti-inflammatory drugs(NSAIDS) (e.g., anaphylactoid reactions and serious skin reactions) 18. Has a history of asthma, nasal polyps, angioneurotic oedema or urticaria after taking aspirin or other NSAIDS 19. Has a history of recurrent peptic ulcer, perforation or gastrointestinal bleeding, related to previous NSAIDS therapy 20. Uses of any investigational or prohibited drugs per protocol 21. Has liver cirrhosis 22. Currently has and/or has a history of liver tumors (benign or malignant) 23. Knows of active liver disease 24. Knows of active renal disease 25. Plans to move to another location in the next 8 months that would interfere with trial participation 26. Has previously participated in this trial 27. Is currently participating in another clinical trial 28. Has any condition (social or medical) which in the opinion of the site investigator would make trial participation unsafe, would interfere with adherence to trial requirements or complicate data interpretation
Countries
Dominican Republic
Contacts
Public ContactDebra Kozlowski
Outcome results
None listed