WO2018031576A1 - Système et procédé d'administration d'hormones - Google Patents

Système et procédé d'administration d'hormones Download PDF

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Publication number
WO2018031576A1
WO2018031576A1 PCT/US2017/045952 US2017045952W WO2018031576A1 WO 2018031576 A1 WO2018031576 A1 WO 2018031576A1 US 2017045952 W US2017045952 W US 2017045952W WO 2018031576 A1 WO2018031576 A1 WO 2018031576A1
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WIPO (PCT)
Prior art keywords
packaged
bio
delivery system
progesterone
list
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Application number
PCT/US2017/045952
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English (en)
Inventor
Karan Y. BAUCOM
Original Assignee
Baucom Karan Y
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Filing date
Publication date
Priority claimed from US15/231,448 external-priority patent/US9795617B2/en
Application filed by Baucom Karan Y filed Critical Baucom Karan Y
Priority claimed from US15/671,799 external-priority patent/US20170333447A1/en
Publication of WO2018031576A1 publication Critical patent/WO2018031576A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • A61K38/063—Glutathione
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the present disclosed technology relates generally to the administration of human hormones, and in particular to various delivery methods of bioidentical hormone formulations.
  • Hormones are chemical substances produced by cells and organs of the body that affect organs and body systems. Hormones are important for cardiovascular
  • the body's production of hormones and how the body reacts to hormones affect the well-being of individuals and the aforementioned body systems.
  • the body has three general categories of sex hormones; androgens (ex.
  • testosterone testosterone
  • estrogens estradiol and estrone
  • progestagens ex. progesterone
  • Particular female sex hormones and their associated organs are, for example, testosterone (ovaries), estrone and estradiol (ovaries), and progesterone (ovaries and placenta).
  • Testosterone promotes the growth and maintenance of the skeletal system, musculature, and connective tissues, to name a few. Estradiol and estrone principally affect the female reproductive system. Progesterone affects the female menstrual cycle, and maintenance of pregnancy. Hormone deficiencies caused by aging, disease states, exogenous and endogenous environmental conditions, and certain prescribed medications can upset the balance of sex hormones within the body and affect general well-being, lifespan, quality of life, and may lead to disease states as well. Therefore, in order to counter the negative effects of hormone deficiencies, patients are often prescribed hormone replacement therapy (HRT) by their treating physicians.
  • HRT hormone replacement therapy
  • HRT is a system of treatment using either synthetic sex hormones, or bioidentical sex hormones to treat the effects of diminished sexual hormone levels in peri- menopausal, menopausal, and post-menopausal women.
  • Synthetic sex hormones are the predominant type of hormone proscribed in HRT.
  • the types of techniques used in HRT to deliver sex hormones include pills, capsules, gels, creams, patches and troches.
  • Use of synthetic sex hormones in HRT comes with significant problems such as heart problems, cancers and other undesirable side effects.
  • the type and amount of sex hormone administered is limited by dosing regimens associated with the available delivery techniques.
  • a hormone delivery system providing for administration of bioidentical human hormones using a combination of modalities for the treatment of human physiological conditions where treatment by hormone therapy is indicated.
  • Bioidentical estrogen, progesterone and androgen preparations may be administered individually, or in combination to a patient using one or more modalities such as transdermal absorption or ingestion.
  • the hormone delivery system can be used to treat pre-menstrual tension syndrome, peri-menopause, menopause, post-menopause, progesterone deficiency, estrogen dominance, libido issues, and birth control.
  • a "steady state” occurs where there is little or no bleeding during the secretory phase. This is based upon the endometrial layer being so scant that the progesterone does not induce bleeding. Previously it was a concern that the endometrial layer would remain and become exposed to the estrogenic component. However, as long as progesterone is also being introduced, there is a ratio that results in an equilibrium wherein the endometrial layer neither grows nor sheds.
  • Estrogen dominance can occur when large doses of estrogen are
  • progesterone predominantly utilized without being balanced out with progesterone. Inducement of the cycle with the use of progesterone with the intact uterus can help to prevent endometrial hyperplasia. Therefore, any female patient utilizing estrogen in a delivery system should also balance that with progesterone.
  • progesterone used is also important. Oral micronized is also important. Oral micronized is also important.
  • progesterone and various progestogens are available.
  • Progestogens include natural progesterone and synthetic progestins.
  • An embodiment of the present invention presents a hormone delivery system
  • HDS which provides the hormones to the patient in a biologically, physiological manner which simulates the menstrual cycle.
  • Transdermal applications include patches, gels, creams, or some combination thereof.
  • the estrogen must be presented in a transdermal application, but the progesterone could also be presented orally, such as in a capsule.
  • the advantage of the present invention is to provide an HDS that is modifiable by the treating physician by adjusting the dosages. As an example, using gels and creams, the physician can prescribe 25 milligrams per application. The hormones being provided through the HDS are well suited for these variations.
  • FIG. 1 box diagram illustrating the relationship between various elements of an embodiment of the present invention.
  • Fig. 2 is a chart diagramming a timeline based upon various elements and aspects of the present invention.
  • Fig. 3 is diagrammatic representation of a sample Steriodogenic pathway.
  • Fig. 4 is a pie chart diagramming an optimal balance of estrogen metabolites.
  • Fig. 5 is a pie chart diagramming an optimal balance of estrogen metabolites.
  • the hormone delivery system embodying the principles of the disclosed technology provides for administration of compositions containing bioidentical human hormones in an amount sufficient to provide therapeutic effect, using a combination of modalities, for the treatment of human physiologic conditions.
  • specific bioidentical hormones which may be used include, but are not limited to estrogens (estrone, estradiol), progesterone, and androgens (testosterone, androstenedione, dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA)) isomers and derivatives thereof, and combinations thereof.
  • Examples of specific modalities which may be used include, but are not limited to topical preparations (gel, cream), ingested articles (tablet, lozenge, capsule, troches), and articles for transdermal absorption of hormone preparations (transdermal patch, impregnated matrices).
  • topical preparations gel, cream
  • ingested articles tablette, troches
  • articles for transdermal absorption of hormone preparations transdermal patch, impregnated matrices.
  • the type and amount of hormones involved in the various bioidentical human hormone compositions, and the modalities used varies depending independently, or in conjunction with, the physiologic sequence based on the normal menstrual cycle pattern, and specific clinical syndromes involved.
  • a single bioidentical hormone or a combination of bioidentical hormones may be used with any particular modality.
  • the hormone delivery system may be used for the treatment of conditions related to hormone imbalances or deficiencies where treatment by hormone therapy is indicated.
  • the types of conditions for which the hormone delivery system may be used include, but are not limited to: pre-menstrual tension syndrome; peri-menopause, menopause, post-menopause; progesterone deficiency; estrogen dominance; and libido issues.
  • Additional treatment measures include providing birth control.
  • the hormone delivery system is used in conjunction with indole-
  • a pre-packaged hormone delivery system (HDS) 2 comprising another embodiment or aspect of the disclosed technology can be used for treating peri-menopause, menopause and post-menopause.
  • the bioidentical human hormones estrogens 4 (estrone, estradiol) and progesterone 6 using a combination of modalities mentioned above are administered to a patient in a sequential format following the human physiological twenty-eight day menstrual cycle as diagrammed in Fig. 2. Any combination of patches, capsules and other types of delivery systems can be utilized, provided the menstrual cycle is simulated.
  • the present invention is pre-packaged for clinical efficiency. This ensures the proper dosage without requiring the physician to mix and match the estrogen and the progesterone doses separately.
  • the hormones being applied through the delivery system are FDA approved in a therapeutic fashion for hormone replacement therapy. Examples include 17-B estradiol, progesterone, progestogens, and progestins.
  • the delivery system is intended for involving estrogen throughout the standard menstrual cycle (from day one through the entire month) and utilizing progesterone as early as day ten or as late as day fourteen. This ensures progesterone is initiated in addition to the estrogen for the remainder of the cycle. This results in a period primarily during the final 5 days of the month based upon the dosage of estrogen, as it is the estrogen component that proliferates the endometrial lining.
  • the present invention simulates the physiological menstrual cycle as its template, mimicking the normal rhythmic delivery of the sex steroids.
  • Fig. 2 illustrates this in some detail.
  • the graph element 8 illustrates the uterine cycle; namely, the thickness of the endometrial lining during a typical cycle.
  • Element 10 graphs the progesterone hormone level over that cycle, and element 12 illustrates the estradiol level.
  • element 14 illustrates the follicle- stimulating hormone (FSH) while element 16 represents the lutenizing hormone (LH).
  • Body temperature along the cycle is illustrated at element 18.
  • the phases of the cycle are listed at 20.
  • the follicular phase is represented at 22 and the luteal phase at 24.
  • the hormone delivery system of this embodiment provides estrogen and progesterone replacements.
  • the estrogen would be provided via a topical solution such as a gel or cream, but the progesterone could be provided either through a micronized oral progesterone (e.g., capsule, sub lingual, troche, or pill) or through a topical, preferably vaginal, gel, cream, or transdermal spray.
  • Dosage ranges for the progesterone can range between 20 milligrams through 300 milligrams.
  • the 28 day cycle may initiate the progesterone component as early as day 10 or as late as day 14.
  • the component is used cyclically in association with continuous bioidentical estrogen.
  • estrogen can be administered as a patch, gel or cream in suitable dosages of, for example, .25 mg, .375 mg, .5 mg, .75 mg and 1.0 mg.
  • Progesterone can be administered as a patch, gel, cream, capsule or sublingual in suitable dosages of, for example, 25 mg, 50 mg, 75 mg, 100 mg, 200 mg and 300 mg.
  • Di- indole methane/3-indole carbinol (Dim/3IC) can be administered as 400 mg tablets or gels.
  • Dim/3IC Di- indole methane/3-indole carbinol
  • estrogen-dominant patients should only be given progesterone during days 1-25 of their menstrual cycles. If any estrogen is used, an option is to utilize 3IC/Dim for pathway protection for increasing 2-meo/2 hydroxylation excretion. It is generally important for the patient to excrete estrogen.
  • An alternative embodiment of the present invention seeks to treat libido issues, specifically but not exclusively during menopause, by providing a combination of estrogen, testosterone, and progesterone to the patient. Testosterone will be prescribed to the patient from day 7 through day 20 of the 28 day cycle.
  • An alternative embodiment of the present invention uses a combination of estrogen and progesterone at dosages of 25mg, 50mg, lOOmg, or 200mg to treat PMDD, PMS, and/or estrogen dominance. This combination can also be used to treat insomnia in menopausal and post-menopausal women.
  • An alternative embodiment of the present invention uses a combination of estradiol and testosterone to treat vaginal dryness, atrophy, and/or dyspareunia.
  • a combination of 2mg/ml of estradiol and 5mg/ml of testosterone is applied intravaginally 2-3 times per week. This is not to be used for menopausal systemic therapy.
  • An alternative embodiment of the present invention uses a bio-identical progesterone provided to the patient for a twenty-five (25) day cycle during a month. Bio- identical estrogen may also be sequentially added during this process. These applications of bio-identical hormones can be used to treat Dysmenorrhea and PMDS. Dysmenorrhea is the medical term for the painful cramps that may occur immediately before or during the menstrual cycle.
  • Dysmenorrhea There are two types of Dysmenorrhea: primary and secondary.
  • Primary dysmenorrhea is another name for common menstrual cramps. The pain or cramping is felt in the lower abdomen of back. The pain or cramping starts shortly before or at the onset of the period and may continue for one to three days. It can be associated with premenstrual dysmenorrhea syndrome, where a more severe form of dysmenorrhea can occur. Symptoms associated with this form can be depression, anxiety, mood disorders, irritability occurring at least two weeks prior to menses.
  • Secondary dysmenorrhea is pain caused by a disorder in the woman reproductive organs. These cramps begin earlier with the menstrual cycle and last longer. Symptoms of each include: aching pain in the abdomen (sometimes severe); pressure in the abdomen; pain in the hips, lower back, and inner thighs due to cramping; upset stomach; and loose stools.
  • Progesterone for this purpose may be transmitted transdermally or orally.
  • the oral distribution of the progesterone could be combined with estrogen in a sequential format.
  • a delivery system would include a package with 25 pills or some other oral administration of the hormones. These would be taken by the patient in sequential order, and estrogen may be added to the same pills such that estrogen is introduced sequentially as well.
  • Bio-identical Progesterone may be provided in a pre-packaged delivery system sequentially dated for a thirty-day cycle, where the progesterone is provided alone for the first 25 days of the thirty-day cycle.
  • bio-identical progesterone may be provided for days 1-30 of the 30 day cycle and bio-identical estrogen introduced in a separate modality (e.g. a separate pill or other modality) from days 14 - 30.
  • bio- identical estrogen may be provided for days 1-30 of the 30 day cycle and bio-identical progesterone introduced as early as day 10 or as late as day 14 through the end of the 30-day cycle.
  • the treatment should fit the needs of the patient.
  • the pre-packaged hormones are labeled and produced in such a way as to help the patient maintain an orderly cycle of taking the correct hormones on the correct day of the cycle.
  • hormone delivery system in an alternative embodiment hormone delivery system and previously disclosed, the use of a glucuronidating, sulfating, acetylating, and/or methylating agent could be included in place of or in combination with the indole (e.g. Di-indole methane or 3-indole carbinol).
  • glutathione or other powerful anti-oxidants could be used as well in combination with any of these elements. Similar to the function of the Indoles as previously disclosed, these agents can be taken throughout a cycle as described by the present invention to provide a means for eliminating estrogen from the body, where it would otherwise store up harmfully.
  • Methylation could include, but would not be limited to, the introduction of methyl B 12, , trimethylglycine, and/or methyltetrahydro folate (MTHF) or other suitable methylating agent.
  • MTHF methyltetrahydro folate
  • Glucuronidation could be controlled by introducing D-glutarate.
  • Sulfation could be controlled using MSM, broccoli, Brussels sprouts, Ibuprofen, or
  • Acetaminophen Acetyl could be controlled through acetyl-L carnitine.
  • Glutathione could be enhanced through using agents, such as N- Acetyl cysteine (NAC), which is a precursor to glutathione and glutathione itself, could be introduced orally , transdermally or nasal spray.
  • NAC N- Acetyl cysteine
  • Any of these processes can be used to detoxify products as they are downgraded within the body's liver. Introduction of these elements can be used to safely remove the estrogen and other hormones, androgens, and DHEA which are introduced into the body through the present hormone delivery system in a safe way. The results are similar to the use of 3 -indole carbinol (3IC) or Di-indomethane as previously discussed.
  • Cytochrome p450 1B1 (CYP1B 1)
  • Methylation particularly can affect this outcome in a positive way to reduce the likelihood of cancer.
  • An optimal balance of estrogen metabolites FIGs. 4 and 5 show charts which represent this optimal balance.
  • the metabolites in the non-hatched portion are considered protective, whereas metabolites in the hatched portion are associated with an increased risk of auto-immune disease, breast, and prostate cancer.
  • the heavy lines separate the Phase 1 and Phase 2 detoxification pathways.
  • Phase 2 metabolism is a process whereby a compound is first subject to oxidation reduction or hydrolysis (Phase 1 reactions), which may be associated with bioactivation, and then the functional group created is conjugated to a less toxic or inactive compound.
  • Phase 1 reactions oxidation reduction or hydrolysis
  • Glucuronides, methylides, sulfides, and the other compounds discussed herein produce this result.
  • hormone delivery system can be used for various other applications.
  • hormone delivery system can be fabricated in various sizes and dosages and from a wide range of suitable materials, using various manufacturing and fabrication techniques

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Abstract

La présente invention concerne un système et un procédé d'administration d'hormones pré-conditionné permettant d'administrer des hormones humaines bio-identiques à l'aide d'une combinaison de modalités pour le traitement de pathologies physiologiques humaines. Une combinaison d'indoles, de glutathion, d'agents de méthylation, d'agents de glucuronidation, d'agents de sulfatation, et d'agents d'acétylation est utilisée en association avec des progestérones et des œstrogènes bio-identiques pour éliminer en toute sécurité l'œstrogène du système à titre d'étape standard dans le processus du système de traitement hormonal.
PCT/US2017/045952 2016-08-08 2017-08-08 Système et procédé d'administration d'hormones WO2018031576A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US15/231,448 US9795617B2 (en) 2009-06-18 2016-08-08 Hormone delivery system and method
US15/231,448 2016-08-08
US15/671,799 2017-08-08
US15/671,799 US20170333447A1 (en) 2009-06-18 2017-08-08 Hormone delivery system and method

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WO2018031576A1 true WO2018031576A1 (fr) 2018-02-15

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