Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis

Exclusion Criteria

• •1. Females younger than 30 years of age or older than 75 years of age.
• •2. Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening.
• •3. Greater than 5% superficial cells on vaginal cytology.
• •4. Vaginal pH ≤5.
• •5. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study participant at undue risk by participation or could jeopardize the integrity of the study evaluations.
• •6. Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Participants with an endometrial thickness equal to or greater than 4 mm.
• •7. Documented PAP smear conducted within the previous 12 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
• •8. Participants with known concurrent vaginal infections including but not limited to:
• •Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis.
• •9. Participants with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day.
• •10. Participants with known, suspected, or current history of carcinoma of the breast. All participants over the age of 40 must have had a mammogram performed within 9 months of the study start and all participants will have a physical breast exam performed at Screening.
• •11. Participants with known, suspected or current history of hormone dependent tumor.
• •12. Participants with baseline systolic blood pressure of \>150 millimetres of mercury (mmHg) and/or diastolic pressure \>90 mmHg.
• •13. Any participant with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
• •14. Any history of estrogen-dependent neoplasia (for example, endometrial cancer).
• •15. History of acute thrombophlebitis or thromboembolic disorder.
• •16. Any current or recent (within the previous 6 months) genital bleeding of unknown etiology.
• •17. Any prescription treatment or over-the-counter (OTC) or natural remedies for vaginal dryness/irritation within 28 days of Screening. Products used for lubrication during sexual intercourse within 7 days of Screening.
• •18. Participants whose fasting triglyceride levels are greater than 350 mg/dL.
• •19. Any participant with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
• •20. Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the participant.
• •21. Participants who have used vaginal hormonal products (rings, creams, gels) within the 28 days prior to Screening.
• •22. Any participant who has used transdermal estrogen and/or progestin therapy within the 28 days prior to Screening.
• •23. Participants who have used oral estrogen and/ or progestin therapy or intrauterine progestin therapy within the 56 days prior to Screening.
• •24. Participants who have used progestin implants or estrogen alone injectable drug therapy within the 3 months before Screening.
• •25. Participants who have used estrogen pellet therapy or progestin injectable drug therapy within the 6 months before Screening.
• •26. Participants who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
• •27. Participants who are unable or unwilling to give informed consent.
• •28. Receipt of any drug as part of a research study within 30 days prior to Screening.
• •29. Participants who have participated in this study previously.