Detection of menopause status and treatment thereof

The method of treating a human female menopausal condition, the steps that include determining need for increasing estrogen level in the blood, from a lower level associated with reduced ovarian estrogen production, the determining including measuring vaginal moisture or urethral fluid pH level, at repeated time intervals over a series of days. A test for FSH level in the blood, during those days, may be made for detection of high level FSH in conjunction with high pH level at the vagina to establish need for estrogen therapy, on a confirmatory basis.

BACKGROUND OF THE INVENTION

This invention relates generally to factors involved in determining estrogen or estradiol administration to human females who are menopausal; and more particularly to a simple and effective diagnostic method and means to effect such determination such as need for changes in dosage of estrogen or estradiol.

There is need for improvements in methods to determine whether or not a human menopausal female should be administered higher or lower levels of estrogen or estradiol. Such need can arise for example in evaluation and diagnosis of female sexual dysfunction (FSD). It appears that lack of estrogen may lead to sexual dysfunction primarily by causing vaginal atrophy and dyspareunia. Another example of need is for treatment of postmenopausal fracture, as in the case of osteoporosis. The present invention addresses such need or needs.

There is also need for a low-cost, diagnostic procedure useful to determine, or screen for, menopausal condition or status, in women, and to provide and monitor a remedy for that condition.

In addition, when FSH level in the blood is monitored, there is need for a simple confirmatory or supplementary test, for estrogen need.

SUMMARY OF THE INVENTION

It is a major object of the invention to provide a self-diagnostic procedure, enabling menopausal women to determine need for estrogen therapy, i.e. need to supply estrogen to the body, to compensate for reduction in ovarian estrogen supply. The needed procedure contemplates a protocol enabling reduction in vaginal pH level from about 6.0 (for menopausal women) to about 4.5, and which may be measured in conjunction with FSH measurement.

It is another object of the invention to provide a method that includes:

a) determining need for increasing estrogen level in the blood, from a lower level associated with reduced ovarian estrogen production,

b) said determining including measuring vaginal moisture or urethral fluid pH level, at repeated time intervals over a series of days, for example during estrogen therapy.

For example, the method may include periodically administering estrogen or estradiol to the patient, to be transported in the blood, and such administering is preferably repeated to reduce measured vaginal moisture pH level to about 4.5, or to significantly reduce menopausal symptoms.

An added object of the invention is to measure vaginal moisture acidity by employment of an acidity indicator applied proximate a moist wall surface of the vagina. Such an indicator may advantageously exhibit coloration or colorations corresponding to pH level or levels of moisture at the wall surface of the vagina, such colorations being different for different pH levels.

A further object is to provide a pH measurement calorimeter to be positioned to extend for ready comparison with coloration of the material or materials of the indicator, following its use.

An additional objective is to repeat the vaginal moisture pH measurement at time intervals such that vaginal moisture pH level is ultimately determined to have reached a desired level or levels corresponding to reduced observed menopausal symptoms, in a human patient.

A yet further object is to also measure FSH level in the patient's blood, for correlating an increasing FSH level with an increase in said pH level, as an indicator of need for estrogen increase. Such measuring is typically periodic to indicate a timewise increasing FSH level, for such correlation. Estrogen is then administered to the patient as a result of said correlation, and at a relatively low dosage level corresponding generally to healthy ovarian estrogen production level. Such administering is preferably directly into the blood to maximize the estrogen hormone effect on the body, thereby minimizing the amount of estrogen needed. Measurement correlation as referred to provides a confirmatory (FSH level rising, pH level high or rising) indication of need for estrogen. Correlation of these measurements during estrogen therapy provides confirmation of need for estrogen administration.

A yet further object includes provision of a method of determining need for estrogen administration to a human patient that includes:

b) measuring FSH level in the blood,

c) correlating the a) and b) measurements to determine co-existence of relatively high pH and FSH levels,

d) and administering estrogen to the patient as a result of said co-existence correlating.

DETAILED DESCRIPTION

FIG. 1designates generally the step of determining need for increasing estrogen level in the blood, from a lower level associated with reduced ovarian estrogen production level. Numeral110designates monitoring or observation of a patient exhibiting one or more menopausal symptoms, needing treatment or reduction, and typically including:i) insomniaii) emotional instabilityiii) body hot flashesiv) vaginal drynessv) urogenital symptoms.

SuchFIG. 1determination includes measuring vaginal moisture, or urethral fluid, pH level, at repeated time intervals, over a series of days. Block111schematically designates application of measurement means to the vagina, as by use of the probe10, which may have the general form of the applicator or probe10disclosed in U.S. Pat. No. 6,406,441, incorporated herein by reference.

The test element30at the side of the probe, near its tip31, is employed at111, as by pressing the element toward and against the vaginal wall. Element30typically comprises a pH indicator, and may take the form of a NITRAZINE® strip adhered to the side of the probe, as for example by double sided adhesive tape. After exposure of the strip to vaginal moisture, its changed color (according to pH level) is compared with the series20of bands on a support21. Each band has a different color corresponding to a pH level color to which the detector strip may change. See for example the indicated pH levels 4.5, 5.0,m 5.5, 6.0, 6.5, 7.0 and 7.5 adjacent the color bands. The bands may be provided on a strip adhered to the outer surface of the support. Paper strips providing such elements are known, and sold under the name HYDRION papers, by Micro Essential Laboratory Inc., Brooklyn, N.Y. 11210. The band for pH 4.5 is typically bright yellow; the band for pH 6.0 is olive in color; and the band for pH 7.5 is navy blue.

Arrow40indicates removal of the probe from the vagina, for use as depicted, proximate the calorimeter bands. Arrow41indicates periodic progress of a succession of probes and test elements30in a direction corresponding to lowered pH level associated with periodic estrogen administration to the menopausal patient. That direction is also an indicator of gradual reduction of menopausal symptoms, whereby when the color of a test element30corresponds to the color of the pH 4.5 band, the patient's estrogen deficiency caused menopausal symptoms have been significantly reduced, or eliminated. In this regard, a different probe10and/or element30, is normally employed for each of the periodic tests, so that the element30is new, for each test, the different elements indicated for example at30,30′, and30″, at successive leftward positions. The probe handle is seen at10a.

InFIG. 3, the block120represents the vaginal pH determination including pH self-testing as described above, and as for example is represented inFIG. 1. Block121represents a determination of FSH level (follicle stimulating hormone produced by the pituitary) in the blood, as by means of a blood or urine test. In this regard block121may represent a simple test for a timewise sequence of such FSH level tests, as over one or more days intervals, to determine a high or rising FSH level to compensate for very low level or non-existent ovarian estrogen output, to the blood.

Block124, receiving the output122and123from blocks120and121, represents the step of correlating those outputs, for example observing high measured level (15–17) FSH, and in conjunction with high measured level (6.0–6.2) vaginal pH, these together providing a dual confirmatory basis or reason for need of estrogen administration to the patient. Block126represents administration of estrogen to the patient (for example by patch to a limb) as a result of such observed correlation. Such administration can then be initially effected at a relatively low and safer dosage level corresponding generally to healthy ovarian estrogen production level. For example, a low level may be within the range 0.15 to 0.165 milligrams, per day. As estrogen therapy continues, the levels of the measurement outputs at120and121can be correlated to indicate reduction in both levels to normal, at which the corresponding confirmed estrogen need level is established.