A clinical study to evaluate the efficacy and safety of generic conjugated estrogens vaginal cream compared with Premarin® Cream(Conjugated estrogens) in healthy postmenopausal women with vulvar and vaginal atrophy.
- Conditions
- Health Condition 1: N768- Other specified inflammation of vagina and vulva
- Registration Number
- CTRI/2024/08/072592
- Lead Sponsor
- ovast Laboratories, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Postmenopausal females aged 40 years or more willing to give informed consent. Postmenopausal is defined as:
a) at least 12 months of spontaneous amenorrhea OR
b) at least 6 months of spontaneous amenorrhea with serum FSH levels more than 40 mIU/mL
c) 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy at the screening.
2.Patient with at least 48 kg with Body Mass Index less than or equal to 38 Kg/m2 and greater than or equal to 19 Kg/m2.
3.Postmenopausal female with less than or equal to 5% superficial cells on vaginal smear cytology at the screening visit.
4.Postmenopausal female with Vaginal pH more than 5.0 at the screening visit and randomization visit.
5.Postmenopausal female with at least one of the following patients self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the Patient as being Most Bothersome Symptom (MBS) to her:
a)Vaginal dryness
b)Vaginal and/or vulvar irritation/itching
c)Dysuria
d)Vaginal pain associated with sexual activity
e)Vaginal bleeding associated with sexual activity
6.Patient with normal or non-clinically significant results below:
a)12-lead ECG
b)Physical examination, including vital signs
c)Pelvic examination that was consistent with hypoestrogenemia
d)Physical examination of Breast
e)Mammogram (Documentation of a negative mammogram obtained at screening or within 9 months before screening)
f)Laboratory evaluation results (Serum Chemistry, Hematology, Coagulogram, and Urinalysis). For this 10 ml of blood will be collected from each patient
g)Patients with any abnormal gynecological findings other than symptoms of vulvar and vaginal atrophy.
7.Patients with intact uterus vaginal ultrasonography at screening show an endometrial thickness of less than 4 mm.
8.Documented papanicolaou (PAP) smear conducted within the previous 3 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
9.In the opinion of the investigator, the patient will comply with the protocol and has a high probability of completing the study.
10.Patient willing to provide written consent, as appropriate.
11.Patient willing and able to understand and comply with the requirements of the study, apply the medication as instructed including the ability to use the applicator properly, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
1.Patient with known, suspected, or current history of carcinoma of the breast.
2.Patient with known, suspected, or history of cervical cancer or any other known or suspected hormone-dependent neoplasia.
3.Patient with a serum FSH level of less than or equal to 40mIU/mL at screening.
4.Patient with significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that in the Investigator’s opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
5.Patients with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Patients with an endometrial thickness of 4 mm and greater.
6.Documented PAP smear conducted within the previous 3 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
7.Known hypersensitivity (anaphylactic reaction or angioedema) to conjugated vaginal cream or any component of the study medication.
8.Patient with undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
9.Patient has taken any prescription treatment or over-the-counter or natural remedies for vaginal dryness/irritation within 28 days of screening. Products used for lubrication during sexual intercourse within 7 days of screening.
10.Patient with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day.
11.Patient with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis.
12.Patient on medication indicated for anticoagulation which includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc.
13.Patient who had engaged in sexual intercourse within 48 hours (2 days) of screening.
14.Patients whose fasting triglyceride levels are greater than 350 mg/dL.
15.Patient with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
16.Patient with known or history with abnormalities in blood pressure (sustained systolic blood pressure more than 150 mm Hg and/or diastolic blood pressure more than 90mm Hg), and/or other cardiovascular diseases, deep vein thrombosis, pulmonary embolism or liver dysfunction, or liver disease.
17.Patient with known clinically significant gallbladder dysfunction/disorders.
18.Patient with history or active arterial thromboembolic disease (e.g., stroke, myocardial infarction) or thrombophlebitis or on prolonged bed rest.
19.Patient with known uncontrolled hypothyroidism.
20.Urinalysis showing an ongoing clinically significant urinary tract infection that requires treatment.
21.Patient with known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
22.Patient on hormonal replacement therapies before screening as follows:
•within 2 weeks of baseline assessment for vaginal therapy (rings, creams, gels)
•within 4 weeks of baseline assessment for transdermal estrogen alone or estrogen/progestin therapy
•within 8 weeks of baseline assessment for oral estrogen and/or progestin thera
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients that are identified as responders i.e Patient with at least 25 percent reduction from baseline on vaginal cytology AND Vaginal pH less 5.0 with a change from baseline vaginal pH of at least 0.5 in all the treatment groupsTimepoint: Screening and Day 22
- Secondary Outcome Measures
Name Time Method Proportion of patients with Treatment success (The patient who achieved a score of less than or equal to 1 for vaginal dryness, vaginal or vulvar irritation or itching, dysuria or vaginal pain associated with sexual activity, or a result of absence if her MBS was vaginal bleeding with sexual activity on Study Day 22 for the most bothersome symptom as identified by the patient at baseline will be considered a treatment success.)Timepoint: Screening and Day 22