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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | Experimental | 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. |
|
| Estrace Vaginal Cream USP, 0.01% | Active Comparator | 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. |
|
| Vehicle Vaginal Cream | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | Drug | Vaginal cream, generic formulation of the brand product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 9 |
| 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. | Up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
"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:
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.
Participants who have used estrogen pellet therapy or progestin injectable drug therapy within the 6 months before Screening.
Participants who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
Participants who are unable or unwilling to give informed consent.
Receipt of any drug as part of a research study within 30 days prior to Screening.
Participants who have participated in this study previously.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Teva Pharmaceuticals USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number 44 | Tucson | Arizona | 85710 | United States | ||
| Site Number 17 |
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Following the 14-day screening period, participants who continued to meet the inclusion/exclusion (I/E) criteria were randomly assigned to treatment on a 2:2:1 ratio of generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01%; Estrace Vaginal Cream USP, 0.01%; or vehicle vaginal cream.
The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Generic Estradiol Vaginal Cream USP, 0.01% | Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| FG001 | Estrace Vaginal Cream USP, 0.01% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2016 | Dec 11, 2019 |
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| Estrace® Vaginal Cream USP, 0.01% | Drug | Vaginal cream, brand product. |
|
| Vehicle Vaginal Cream | Drug | Vaginal cream, placebo. Has no active ingredient |
|
| Up to Day 9 |
| 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. | Up to 9 months |
| 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 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 30 | Miami Lakes | Florida | 33014 | 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 10 | Sarasota | Florida | 34239 | United States |
| Site Number 19 | St. Petersburg | Florida | 33709 | 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 | Mt. 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 |
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. |
| FG002 | 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. |
| Safety Population | All participants who were randomized and administered at least 1 dose of study drug |
|
| mITT Population | mITT population, administered at least 1 dose of study drug, and had a post-randomization evaluation |
|
| PP Population | Met I/E criteria, didn't develop concurrent vaginal infection, completed Day 8 visit, took 6-8 doses |
|
| COMPLETED |
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| NOT COMPLETED |
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|
All participants who were randomized and administered at least 1 dose of study drug (Safety Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Generic Estradiol Vaginal Cream USP, 0.01% | Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Percent of Basal/Parabasal Cells | All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data. | Mean | Standard Deviation | percent of cells |
| |||||||||
| Percent of Intermediate Cells | All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data. | Mean | Standard Deviation | percent of cells |
| |||||||||
| Vaginal pH | Mean | Standard Deviation | pH |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who met I/E criteria, didn't develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn't miss >1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis. | Posted | Count of Participants | Participants | Up to Day 9 |
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| Primary | 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. | Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using Last Observation Carried Forward (LOCF). | Posted | Count of Participants | Participants | Up to Day 9 |
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| Secondary | 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. | Participants who met I/E criteria, didn't develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn't miss >1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis. | Posted | Count of Participants | Participants | Up to Day 9 |
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| Secondary | 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. | Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using LOCF. | Posted | Count of Participants | Participants | Up to 9 months |
|
Baseline up to Day 9
All participants who were randomized and administered at least 1 dose of study drug (Safety Population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Generic Estradiol Vaginal Cream USP, 0.01% | Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. | 0 | 267 | 0 | 267 | 63 | 267 |
| EG001 | 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. | 0 | 262 | 1 | 262 | 74 | 262 |
| EG002 | 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. | 0 | 132 | 0 | 132 | 25 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device occlusion | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Application site warmth | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Mucosal excoriation | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cyclic vomiting syndrome | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometrial thickening | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine spasm | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine tenderness | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vaginal erosion | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vaginismus | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal erythema | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal swelling | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pterygium operation | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, CE Studies | Teva Pharmaceuticals USA, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 18, 2016 | Dec 11, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
|
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| OG002 |
| 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. |
|
|
|
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. |
|
|
|
| OG002 | 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. |
|
|
|