Methods for assessing, improving, or maintaining urogenital health in postmenopausal women
OwnerWesley W. Day, Andrew G. Lee +1inventors
InventorsWesley W. Day, Andrew G. Lee, David D. Thompson
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Abstract
This invention relates to methods and kits useful for improving or maintaining urogenital health using an estrogen agonist/antagonist. The methods of treatment are effective for improving or maintaining urogenital health while substantially reducing the concomitant liability of adverse effects associated with estrogen administration. This invention also relates to methods of assessing vaginal health.
Claims104
A method for improving or maintaining urogenital health comprising administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of lowering vaginal pH, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating an urinary tract infection, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating vaginal dryness, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating vaginal itching, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating undesired vaginal spasms, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating vaginitis, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating a vaginal yeast or bacterial infection, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating vulvar atrophy, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating urethrocele, cystocele, rectocele or enterocele prolapse, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating urinary or anal incontinence, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of treating undesired urinary frequency or urgency, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A method of increasing the frequency or intensity of orgasms in a female patient, the method comprising the step of administering to a patient in need thereof a therapeutically effective amount of an estrogen agonist/antagonist.
A kit for use by a consumer to improve or maintain urogenital health comprising:
- (a) a pharmaceutical composition comprising an estrogen agonist/antagonist and a pharmaceutically acceptable carrier, vehicle or diluent;
- and
- (b) instructions describing a method of using the pharmaceutical composition to improve or maintain urogenital health;
- lower vaginal pH;
- treat urinary tract infections;
- treat vaginal dryness;
- treat vaginal itching;
- treat undesired vaginal spasms;
- treat vaginitis;
- treat vaginal yeast or bacterial infections;
- treat vulvar atrophy;
- treat cystocele, urethocele, rectocele or enterocele prolapse;
- treat urinary or anal incontinence;
- treat undesired urinary frequency or urgency;
- or increase the frequency or intensity of orgasms.
A method for assessing vaginal health in a patient, the method comprising:
- a) conducting a gynecological examination;
- b) measuring the pH of the vagina;
- c) determining the vaginal cell maturation index;
- d) determining vaginal prolapse;
- e) administering a questionnaire to the patient;
- and
- f) measuring plasma hormone levels, whereby the data from steps a-f are considered in their totality in making an assessment of the vaginal health of the patient.
A method for assessing vaginal health in a patient, the method comprising:
- a) conducting a gynecological examination that comprises an internal evaluation of the vagina in which the condition of the vagina is characterized by indicating the condition of the vagina on a continuum using I and III below as endpoints and 11 as the midpoint of the continuum:
- I. no rugae, elasticity non-existent, mucosa is very pale, friable and bleeds to touch, no vaginal depth and very dry;
- II. few rugae, loss of some moisture, mild elastic discomfort on exam, pale color, shortening of vaginal length;
- or
- III. normal estrogenized vagina, rugae, good elasticity, pink robust mucosa, good vaginal moisture and good vaginal length;
- and
- assessing the quantity of pubic hair and the thickness of the vulva;
- b) measuring the pH of the vagina;
- c) determining the vaginal cell maturation index;
- d) determining vaginal prolapse using the following scale:
- 8 Grade 0 normal position inside the mid-vaginal axis for anterior posterior wall prolapse and above the ischial spines for cervical or vaginal cuff. By definition, the most apical point is −3 cm superior to the hymen. Grade 1 if the prolapse crosses the respective thresholds and descends halfway to the hymen Grade 2 decent to the hymen Grade 3 decent 2 cm beyond the hymen Grade 4 maximum possible descent for each site. A complete eversion is about 5 cm beyond hymen.
- e) administering a questionnaire to the patient, the questionnaire comprising questions relating to:
- 1) the number of vaginal infections in a specified time period;
- 2) the number of urinary infections in a specified time period;
- 3) the amount of urinary leakage in a specified time period;
- 4) the degree of vaginal dryness in a specified time period;
- 5) the degree of vaginal itching;
- and
- 6) a subjective assessment of overall vaginal health by the patient;
- and
- f) measuring plasma levels of estradiol, luteinizing hormone, follicle-stimulating hormone, testosterone and androstenedione, whereby the data from steps a-f are considered in their totality in making an assessment of the vaginal health of the patient.
Dependencies are inferred from the claim text.