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CompletedNCT03294538Updated Dec 26, 2019Results posted

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

A Phase 3 interventional study of Generic Estradiol Vaginal Cream USP, 0.01% and Estrace® Vaginal Cream USP, 0.01% in Atrophic Vaginitis, sponsored by Actavis Inc.. Completed at 44 sites in United States. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-26.

Sponsored by Actavis Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2016, registered Sep 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
663
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Atrophic Vaginitis with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Atrophic Vaginitis · United States.

Enrollment
2nd of 23
663 · median 69
Started
2016
with 1 other
Phase 3
11 of 23
none open now
Registered
17th of 23
by date
Lead sponsor
1 of 23
Actavis Inc.

Among the 23 studies in Atrophic Vaginitis with a site in United States, this one is the 2nd largest by enrollment, is one of 2 that started in 2016, is one of 11 in phase 3, and was the 17th registered.

By phase

23 studies; the count open now beside each. This study's row is marked.

Phase 3this study11 · 0 open
Phase 45 · 1 open
No phase4 · 1 open
Phase 12 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2005; this study’s year is marked. 2 started in 2016.

Size and results

Median enrollment 69 across the 23 interventional studies. Of the 21 that completed or were terminated, 12 (57%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 23 studies in Atrophic Vaginitis with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

Systemic (oral or transdermal patch administration) estrogen therapies have been shown to effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing the unwanted side effects associated with systemic delivery systems. Low dose, topical estrogen therapy is considered most appropriate and convenient for the treatment of vaginal symptoms associated with menopause, particularly when other symptoms including bone loss or vasomotor dysfunction do not need to be targeted.

03

Conditions studied

  • Atrophic Vaginitis

Browse trials for

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations.
  • Females aged 30-75 years inclusive who are , 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:

    1. Vaginal Dryness
    2. Vaginal and/or vulvar irritation/itching
    3. Dysuria
    4. 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).

Exclusion criteria

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 .
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
663 participants (actual)

Study arms

  • Experimental
    Generic Estradiol Vaginal Cream USP, 0.01%

    Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.

    Drug: Generic Estradiol Vaginal Cream USP, 0.01%

  • Active comparator
    Estrace Vaginal Cream USP, 0.01%

    Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.

    Drug: Estrace® Vaginal Cream USP, 0.01%

  • Placebo comparator
    Vehicle Vaginal Cream

    Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.

    Drug: Vehicle Vaginal Cream

Interventions

  • DrugGeneric Estradiol Vaginal Cream USP, 0.01%

    Vaginal cream, generic formulation of the brand product.

  • DrugEstrace® Vaginal Cream USP, 0.01%

    Vaginal cream, brand product.

  • DrugVehicle Vaginal Cream

    Vaginal cream, placebo. Has no active ingredient

06

What researchers measure

Primary outcomes

  1. Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups

    Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.

    Time frame: Up to Day 9

  2. Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups

    Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.

    Time frame: Up to Day 9

Secondary outcomes

  1. Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups

    The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.

    Time frame: Up to Day 9

  2. Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups

    The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.

    Time frame: Up to 9 months

07

Results

Posted Dec 26, 2019

Participant flow

The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.

Participant flow — Overall Study
MilestoneGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal Cream
Started268262133
Safety population267262132
Mitt population267262132
Pp population244227126
Completed263257131
Not completed552
Withdrew: Adverse event011
Withdrew: Lost to follow-up100
Withdrew: Outside of visit window441

Outcome measures

PrimaryNumber of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups

Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.

Time frame:
Up to Day 9
Reported as:
Count of participants · Participants
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
ParticipantsGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups4944
Statistical analysis
  • Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01% · Odds ratio (or): 0.7 · 90% CI -5.8 to 7.2
PrimaryNumber of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups

Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.

Time frame:
Up to Day 9
Reported as:
Count of participants · Participants
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
ParticipantsGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal Cream
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups53530
Statistical analysis
  • Generic Estradiol Vaginal Cream USP, 0.01% vs Vehicle Vaginal Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 19.9
  • Estrace Vaginal Cream USP, 0.01% vs Vehicle Vaginal Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 20.2
SecondaryNumber of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups

The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.

Time frame:
Up to Day 9
Reported as:
Count of participants · Participants
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
ParticipantsGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups161153
Statistical analysis
  • Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01% · Odds ratio (or): -1.4 · 90% CI -9.0 to 6.2
SecondaryNumber of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups

The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.

Time frame:
Up to 9 months
Reported as:
Count of participants · Participants
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
ParticipantsGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal Cream
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups17516980
Statistical analysis
  • Generic Estradiol Vaginal Cream USP, 0.01% vs Vehicle Vaginal Cream · Cochran-Mantel-Haenszel · p = 0.2897 · Odds ratio (or): 4.9
  • Estrace Vaginal Cream USP, 0.01% vs Vehicle Vaginal Cream · Cochran-Mantel-Haenszel · p = 0.4949 · Odds ratio (or): 3.9

Adverse events

Collected over Baseline up to Day 9. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Generic Estradiol Vaginal Cream USP, 0.01%0/267 (0%)0/267 (0%)63/267 (23.6%)
Estrace Vaginal Cream USP, 0.01%0/262 (0%)1/262 (0.4%)74/262 (28.2%)
Vehicle Vaginal Cream0/132 (0%)0/132 (0%)25/132 (18.9%)
Most frequent serious events
Most frequent serious events
EventGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal Cream
Device occlusionGeneral disorders0/2671/2620/132
Most frequent other events
Showing 10 of 102
Most frequent other events
EventGeneric Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal Cream
Breast tendernessReproductive system and breast disorders13/2679/2621/132
Abdominal painGastrointestinal disorders9/26710/2623/132
Abdominal distensionGastrointestinal disorders3/2678/2620/132
Abdominal pain lowerGastrointestinal disorders7/2673/2620/132
HeadacheNervous system disorders4/2675/2622/132
Nipple painReproductive system and breast disorders2/2674/2620/132
Vulvovaginal discomfortReproductive system and breast disorders1/2674/2621/132
DiarrhoeaGastrointestinal disorders2/2673/2622/132
PainGeneral disorders1/2670/2622/132
Abdominal tendernessGastrointestinal disorders4/2673/2620/132

Baseline characteristics

All participants who were randomized and administered at least 1 dose of study drug (Safety Population).

Age, Continuous
Age, Continuous(Years)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Mean59.5 ± 6.459.5 ± 6.560.8 ± 5.659.9 ± 6.2
Sex: Female, Male
Sex: Female, Male(Participants)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Female267262132661
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Hispanic or Latino798842209
Not Hispanic or Latino18817490452
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
American Indian or Alaska Native2103
Asian5308
Native Hawaiian or Other Pacific Islander0000
Black or African American25241059
White235232121588
More than one race0213
Unknown or Not Reported0000
Percent of Basal/Parabasal Cells
Percent of Basal/Parabasal Cells(percent of cells)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Mean34.4 ± 35.131.5 ± 34.836.3 ± 34.334.1 ± 34.7
Percent of Intermediate Cells
Percent of Intermediate Cells(percent of cells)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Mean64.7 ± 34.567.5 ± 34.362.8 ± 33.965 ± 34.2
Vaginal pH
Vaginal pH(pH)Generic Estradiol Vaginal Cream USP, 0.01%Estrace Vaginal Cream USP, 0.01%Vehicle Vaginal CreamTotal
Mean6.2 ± 0.86.2 ± 0.86.1 ± 0.76.2 ± 0.8
08

Study locations

44 sites
  • Site Number 44
    Tucson, Arizona 85710, United States
  • Site Number 17
    Tucson, Arizona 85712, United States
  • Site Number 31
    La Mesa, California 91942, United States
  • Site Number 11
    Sacramento, California 95821, United States
  • Site Number 05
    San Diego, California 91208, United States
  • Site Number 15
    San Diego, California 92111, United States
  • Site Number 25
    Colorado Springs, Colorado 80923, United States
  • Site Number 01
    Denver, Colorado 80209, United States
  • Site Number 14
    Denver, Colorado 80220, United States
  • Site Number 18
    New London, Connecticut 06320, United States
  • Site Number 06
    Jupiter, Florida 33458, United States
  • Site Number 13
    Lake Worth, Florida 33461, United States
  • Site Number 30
    Miami Lakes, Florida 33014, United States
  • Site Number 27
    Miami, Florida 33015, United States
  • Site Number 40
    Miami, Florida 33130, United States
  • Site Number 20
    Miami, Florida 33136, United States
  • Site Number 39
    Miami, Florida 33144, United States
  • Site Number 38
    Miami, Florida 33186, United States
  • Site Number 08
    New Port Richey, Florida 34652, United States
  • Site Number 03
    Ormond Beach, Florida 32174, United States
  • Site Number 45
    Port Saint Lucie, Florida 34952, United States
  • Site Number 19
    Saint Petersburg, Florida 33709, United States
  • Site Number 10
    Sarasota, Florida 34239, United States
  • Site Number 02
    West Palm Beach, Florida 33409, United States
  • Site Number 29
    Roswell, Georgia 30075, United States
  • Site Number 22
    Savannah, Georgia 31406, United States
  • Site Number 21
    Wichita, Kansas 67226, United States
  • Site Number 33
    Metairie, Louisiana 70001, United States
  • Site Number 16
    Kalamazoo, Michigan 49009, United States
  • Site Number 34
    Saginaw, Michigan 48604, United States
  • Site Number 35
    Lincoln, Nebraska 68510, United States
  • Site Number 12
    Lawrenceville, New Jersey 08648, United States
  • Site Number 26
    Plainsboro, New Jersey 08536, United States
  • Site Number 36
    Raleigh, North Carolina 27607, United States
  • Site Number 04
    Winston-Salem, North Carolina 27103, United States
  • Site Number 37
    Winston-Salem, North Carolina 27103, United States
  • Site Number 07
    Columbus, Ohio 43213, United States
  • Site Number 24
    Englewood, Ohio 45322, United States
  • Site Number 28
    West Chester, Ohio 45069, United States
  • Site Number 23
    Bluffton, South Carolina 29910, United States
  • Site Number 41
    Mount Pleasant, South Carolina 29464, United States
  • Site Number 43
    Myrtle Beach, South Carolina 29572, United States
  • Site Number 32
    Dallas, Texas 75230, United States
  • Site Number 09
    Seattle, Washington 98105, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Feb 2017, 8 months.

Results were first posted in Dec 2019, 2 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 27, 2017
StartActual
May 18, 2016
Primary completionActual
Feb 15, 2017
CompletionActual
Feb 15, 2017
Results first posted
Dec 26, 2019
Last update
Dec 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03294538
Lead sponsor
Actavis Inc.
Collaborators
Teva Pharmaceuticals USA
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
May 18, 2016
Primary completion
Feb 15, 2017
Completion
Feb 15, 2017
Results posted
Dec 26, 2019
Last update
Dec 26, 2019

Study contacts

Study Director
study director · Teva Pharmaceuticals USA

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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