Hormone Replacement Therapy Will Be Available Over-The-Counter In The UK In September—We Wish The U.S. Would Follow Suit

[Nelson Vergel]

Gina 10 microgram vaginal tablets (containing estradiol) will be available from pharmacies without a prescription.

Hormone Replacement Therapy Will Be Available Over-The-Counter In The UK In September—We Wish The U.S. Would Follow Suit

It's time to reframe the narrative around HRT.

www.suggest.com

 

[Dicky]

Gina 10 microgram vaginal tablets (containing estradiol) will be available from pharmacies without a prescription.

Hormone Replacement Therapy Will Be Available Over-The-Counter In The UK In September—We Wish The U.S. Would Follow Suit

It's time to reframe the narrative around HRT.

www.suggest.com

I am happy for my sisters in the UK. I would hope that one day HRT for men would be available over the counter. I'll not be holding my breath waiting though.

 

[BigTex]

Not so sure they are doing post menopausal a favor. Putting them all on estrogen tabs is risky. Doctors here do the same when many need testosterone replacement. My wife never took birth control pills nor will she take estrogen pills now.

 

[DorianGray]

I think their playing with dynamite without a well-versed in HRT doctor's supervision.

 

[madman]

Gina 10 microgram vaginal tablets (containing estradiol) will be available from pharmacies without a prescription.

Hormone Replacement Therapy Will Be Available Over-The-Counter In The UK In September—We Wish The U.S. Would Follow Suit

It's time to reframe the narrative around HRT.

www.suggest.com

SUMMARY OF PRODUCT CHARACTERISTICS


1 NAME OF THE MEDICINAL PRODUCT

Gina 10 micrograms vaginal tablets.


2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vaginal tablet contains: Estradiol hemihydrate equivalent to estradiol 10 micrograms. For the full list of excipients, see section 6.1


3 PHARMACEUTICAL FORM

Vaginal tablet. White, film-coated, biconvex tablet engraved with NOVO 278 on one side. Diameter 6 mm.


4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year (see section 5.1)


4.2 Posology and method of administration

Gina is administered intravaginally as a local estrogen therapy by use of an applicator.

Initial dose: One vaginal tablet daily for two weeks.
Maintenance dose: One vaginal tablet twice a week.

Reinstituting treatment: For patients still experiencing symptom relief after a break from therapy, it is recommended that treatment is restarted at the maintenance dose. For patients experiencing bothersome symptoms again after a break from therapy, it is recommended to restart treatment at the initial daily dose regimen for 2 weeks, followed by the maintenance twice weekly dose.

Switching from other local vaginal estrogen preparations: Patients experiencing symptom relief from vaginal estrogen preparations that are being used at the recommended dose can be switched to the maintenance dose of Gina provided:

• The woman has used her current vaginal estrogen product for more than 3 months, and;
• Her symptoms are adequately controlled, and;
• Her health status is unchanged since her last prescription


Treatment may be started on any convenient day.

If a dose is forgotten, it should be used as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

For estrogen products for the vaginal application of which the systemic exposure to the estrogen remains within the normal postmenopausal range, such as Gina, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’).

Gina may be used in women with or without an intact uterus


Method of administration:

1. Open the blister pack at the plunger end.
2. Insert the applicator in the vagina until resistance is met (8-10 cm).
3. Release the tablet by pressing the plunger.
4. Withdraw the applicator and discard.


5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Natural and semisynthetic estrogens, plain.

ATC code: G03CA03

The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.


Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics. The biological effect of 17β-estradiol is carried out through a number of specific estrogen receptors. The steroid receptor complex is bound to the cell's DNA and induces the synthesis of specific proteins.

Maturation of the vaginal epithelium is dependent upon estrogens. Estrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in the vaginal smear.

Estrogens maintain vaginal pH around the normal range (4.5) which enhances normal bacterial flora.

Treatment of vaginal estrogen deficiency symptoms: vaginally applied estrogen alleviates the symptoms of vaginal atrophy due to estrogen deficiency in postmenopausal women


A 12-month, double-blind, randomized, parallel-group, placebo-controlled, multicentre study was conducted to evaluate the efficacy and safety of estradiol 10 micrograms vaginal tablets in the treatment of postmenopausal vaginal atrophy symptoms.

After 12 weeks of treatment with estradiol 10 micrograms vaginal tablets, the change from baseline, in comparison with placebo treatment, demonstrated significant improvements in the three primary endpoints: Vaginal Maturation Index and Value, normalization of vaginal pH, and relief of the moderate/severe urogenital symptoms considered most bothersome by the subjects.

The effect of treatment on the most bothersome vaginal symptoms (e.g. painful sexual intercourse, vaginal dryness, and itching) became apparent after 4 weeks versus placebo, reaching statistical significance versus placebo after 8 weeks.

Endometrial safety of estradiol 10 micrograms vaginal tablets were evaluated in the above-mentioned trial and a second, open-label, multicentre trial. In total, 386 women underwent endometrial biopsy at the beginning and at the end of 52 weeks of treatment. The incidence rate of hyperplasia and/or carcinoma was 0.52% (95% CI 0.06%, 1.86%), indicating no increased risk.




5.2 Pharmacokinetic properties

Absorption

Estrogens are well absorbed through the skin, mucous membranes, and the gastrointestinal tract. After vaginal administration, estradiol is absorbed circumventing first-pass metabolism.

A 12-weeks, single-center, randomized, open-label, multiple-dose, parallel-group trial was conducted to evaluate the extent of systemic absorption of estradiol from the estradiol 10 micrograms vaginal tablet. Subjects were randomized 1:1 to receive either 10 micrograms or 25 micrograms of estradiol vaginal tablets. Plasma levels of estradiol (E2), estrone (E1), and estrone sulfate (E1S) were determined. The AUC(0-24) for plasma E2 levels increased almost proportionally after the administration of 10 micrograms and 25 micrograms of estradiol vaginal tablets. The AUC(0-24) indicated higher systemic estradiol levels for the 10 micrograms E2 tablet as compared to baseline on treatment days 1, 14, and 83, being statistically significant on days 1 and 14 (Table 1). However, average plasma E2 concentrations (Cave (0-24)) on all evaluated days remained within the normal postmenopausal range in all subjects. The data from days 82 and 83 as compared to baseline indicate that there is no cumulative effect during twice-weekly maintenance therapy.

The levels of estrone and estrone sulfate seen after 12 weeks of estradiol 10 micrograms vaginal tablets administration did not exceed baseline levels, i.e. no accumulation of estrone or estrone sulfate was observed.

The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin.


Biotransformation

Exogenous estrogens are metabolized in the same manner as endogenous estrogens. The metabolic transformations take place mainly in the liver. Estradiol is converted reversibly to estrone and both can be converted to estriol which is the major urinary metabolite. In postmenopausal women, a significant portion of the circulating estrogens exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens.


Elimination

Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates.


Special patient groups

The extent of systemic absorption of estradiol during treatment with estradiol 10 micrograms vaginal tablets has been evaluated in postmenopausal women aged 60–70 (mean age 65.4) only.


5.3 Preclinical safety data

17-estradiol is a well-known substance. Non-clinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.


6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:
Hypromellose
Lactose monohydrate
Maize starch
Magnesium stearate.

Film-coating:
Hypromellose
Macrogol 6000

 

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