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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrophic Vaginitis

In brief

The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.

Key facts

Study ID

NCT03294538

Run by

Actavis Inc.

People needed

663

Starts

2016-05-18

Expected to finish

2017-02-15

Last updated by the study team

2019-12-26

Who can join

Age: 30 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations.
• Females aged 30-75 years inclusive who are postmenopausal, defined as follows:
• At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) level of >40 milli-international units per milliliter (mIU/mL); at least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy; or hysterectomy without oophorectomy if of age that the Investigator believes would have been naturally reached 12 months of spontaneous amenorrhea.
• Vaginal pH >5.0.
• At least 1 of the following participant self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the participant as being most bothersome to her:
• Vaginal Dryness
• Vaginal and/or vulvar irritation/itching
• Dysuria
• Vaginal pain or bleeding associated with sexual activity, provided that participant is currently sexually active and plans to remain so throughout study.
• "Normal" Screening mammogram completed within 9 months prior to Screening in all participants >40 years old.
• Normal clinical breast examination at the Screening Visit.
• Documented papanicolaou (PAP) smear conducted within the previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
• Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining, defined as endometrial thickness less than 4 millimeters (mm).

You may not qualify if…

• Females younger than 30 years of age or older than 75 years of age.
• Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening.
• Greater than 5% superficial cells on vaginal cytology.
• Vaginal pH ≤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.
• 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.
• Documented PAP smear conducted within the previous 12 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
• Participants with known concurrent vaginal infections including but not limited to:
• Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis.
• Participants with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day.
• 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.
• Participants with known, suspected or current history of hormone dependent tumor.
• Participants with baseline systolic blood pressure of >150 millimetres of mercury (mmHg) and/or diastolic pressure >90 mmHg.
• Any participant with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
• Any history of estrogen-dependent neoplasia (for example, endometrial cancer).
• History of acute thrombophlebitis or thromboembolic disorder.
• Any current or recent (within the previous 6 months) genital bleeding of unknown etiology.
• 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.
• Participants whose fasting triglyceride levels are greater than 350 mg/dL.
• Any participant with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
• Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the participant.
• Participants who have used vaginal hormonal products (rings, creams, gels) within the 28 days prior to Screening.
• Any participant who has used transdermal estrogen and/or progestin therapy within the 28 days prior to Screening.
• Participants who have used oral estrogen and/ or progestin therapy or intrauterine progestin therapy within the 56 days prior to Screening.
• Participants who have used progestin implants or estrogen alone injectable drug therapy within the 3 months before Screening.

Where it is running

• Site Number 44 — Tucson, Arizona, United States
• Site Number 17 — Tucson, Arizona, United States
• Site Number 31 — La Mesa, California, United States
• Site Number 11 — Sacramento, California, United States
• Site Number 05 — San Diego, California, United States
• Site Number 15 — San Diego, California, United States
• Site Number 25 — Colorado Springs, Colorado, United States
• Site Number 01 — Denver, Colorado, United States
• Site Number 14 — Denver, Colorado, United States
• Site Number 18 — New London, Connecticut, United States
• Site Number 06 — Jupiter, Florida, United States
• Site Number 13 — Lake Worth, Florida, United States
• Site Number 27 — Miami, Florida, United States
• Site Number 40 — Miami, Florida, United States
• Site Number 20 — Miami, Florida, United States
• Site Number 39 — Miami, Florida, United States
• Site Number 38 — Miami, Florida, United States
• Site Number 30 — Miami Lakes, Florida, United States
• Site Number 08 — New Port Richey, Florida, United States
• Site Number 03 — Ormond Beach, Florida, United States
• Site Number 45 — Port Saint Lucie, Florida, United States
• Site Number 10 — Sarasota, Florida, United States
• Site Number 19 — St. Petersburg, Florida, United States
• Site Number 02 — West Palm Beach, Florida, United States
• Site Number 29 — Roswell, Georgia, United States

Full record on ClinicalTrials.gov

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