Natural Woman Progesterone Cream by Products of Nature Inc

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Amenorrhea. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for amenorrhea, there is insufficient reliable information about the clinical effects of these products for this condition.
• Benzodiazepine withdrawal. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for benzodiazepine withdrawal, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Cardiovascular disease (CVD). Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for CVD, there is insufficient reliable information about the clinical effects of these products for this condition.
• Cocaine dependence. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for cocaine dependence, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Endometrial hyperplasia. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for endometrial hyperplasia, there is insufficient reliable information about the clinical effects of these products for this condition.
• Fibrocystic breast disease. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for fibrocystic breast disease, there is insufficient reliable information about the clinical effects of these products for this condition.
• Hormone replacement therapy (HRT). Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products as part of HRT, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Infertility. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for infertility, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Lichen sclerosus. It is unclear if topical non-prescription progesterone is beneficial for vaginal lichen sclerosus. Details: A small clinical study in adults with vaginal lichen sclerosus shows that applying topical progesterone 2% is similarly effective to placebo cream, and less effective than applying clobetasol propionate 0.05%, for reducing symptoms of vulval lichen sclerosus (225).
• Mastalgia. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for mastalgia, there is insufficient reliable information about the clinical effects of these products for this condition.
• Menopausal symptoms. It is unclear if topical non-prescription progesterone is beneficial for menopausal symptoms. Details: A small clinical study in postmenopausal adults shows that applying progesterone cream (Progest) for 1 year reduces vasomotor symptoms such as hot flashes in 83% of patients, compared with 19% of those using a placebo cream (224). A systematic review of clinical trials identified one additional small clinical study, which shows taking oral progesterone combined with estrogen for 2 months does not improve vasomotor symptoms in perimenopausal adults (112978).
• Miscarriage. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for prevention of miscarriage, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Osteoporosis. It is unclear if topical non-prescription progesterone is beneficial for osteoporosis. Details: Clinical research in postmenopausal adults shows that topical progesterone does not improve bone mineral density (BMD) when compared with placebo (224,112978). A small clinical study in White postmenopausal adults with osteoporosis shows that applying topical progesterone for 2 years seems to be as effective as consuming isoflavone-containing soy milk for attenuating a reduction in lumbar spine BMD. However, the combination of soy milk plus progesterone seems to result in greater reductions in BMD than either treatment used alone (69859).
• Postpartum depression. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for postpartum depression, there is insufficient reliable information about the clinical effects of these products for this condition.
• Premenstrual syndrome (PMS). Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for PMS, there is insufficient reliable information about the clinical effects of these products for this condition.
• Preterm labor. Although prescription formulations of intravaginal progesterone have been evaluated for the prevention of preterm labor, it is unclear if oral, non-prescription progesterone is beneficial. Details: One clinical study in patients with singleton pregnancies and a history of preterm birth shows that taking oral micronized progesterone 100 mg twice daily, starting at around week 20 of pregnancy and continuing until 36 weeks or delivery, decreases the relative risk of preterm labor by 34% when compared with placebo. For every 5 patients treated with oral progesterone instead of placebo, one additional preterm birth was prevented (97246).
• Traumatic brain injury (TBI). Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for TBI, there is insufficient reliable information about the clinical effects of these products for this purpose.
• Uterine fibroids. Although there is interest in using oral and/or topical progesterone supplements or non-prescription bioidentical progesterone products for uterine fibroids, there is insufficient reliable information about the clinical effects of these products for this condition. More evidence is needed to rate progesterone for these uses.

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LIKELY SAFE ...when prescription progesterone products are used orally and appropriately. Micronized progesterone (Prometrium) is an FDA-approved prescription product and has been safely used in multiple clinical trials lasting up to 3 years (226,228,1216,1220,1221,1224). ...when prescription progesterone or other prescription products are used intravaginally and appropriately, short-term (1225,2031,2032,2033,2034,103173,103175). Progesterone intravaginal gel (Crinone) is an FDA-approved prescription product and has been safely used in trials lasting up to 3 months (1225,2031,2033,2034,2041). ...when prescription progesterone products are used intramuscularly and appropriately, short-term (227,1218,1225,2034,93742,93748). There is insufficient reliable information available about the safety of any form of supplemental or non-prescription bioidentical progesterone products. Limited clinical evidence comparing compounded bioidentical progesterone prepared in non-sterile environments with placebo or FDA-approved progesterone suggests that the compounded preparations may be safe (112978). Other research shows that there are large variations in progesterone concentrations in non-prescription progesterone products, including variability between different compounding pharmacies and within batches from the same compounding pharmacy, suggesting that the actual dose of progesterone received from these products may be unknown (108146,112977).

PREGNANCY: LIKELY UNSAFE
when used orally, intramuscularly, intravaginally, or transdermally for purposes other than medically supervised adjunctive treatment for infertility (15). There is insufficient reliable information available about the safety of any form of supplemental or non-prescription bioidentical progesterone products. Some research has shown that there are large variations in progesterone concentrations in non-prescription progesterone products (108146).

LACTATION:
Insufficient reliable information available; avoid using.

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ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, using estrogen along with progesterone supplements or non-prescription bioidentical progesterone products might alter the effects of estrogen.  Details Concomitant use of estrogen with prescription progesterone products can cause breast tenderness (228). Also, use of conjugated equine estrogens with oral micronized progesterone in postmenopausal patients seems to blunt the beneficial effects of estrogen on the lipoprotein profile (1216), although it might not affect estrogen-induced reduction in plasma lipoprotein (a) (1217). It is unclear if this interaction would be clinically significant with the doses found in oral or topical progesterone supplements or non-prescription bioidentical products.

PACLITAXEL (Abraxane, Onxol) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, using paclitaxel along with progesterone supplements or non-prescription bioidentical progesterone products might increase paclitaxel levels and adverse effects.  Details Human research suggests that administering high-dose progesterone intravenously along with paclitaxel can increase plasma levels of paclitaxel without affecting neutrophil and platelet nadir counts (21359). It is unclear if this interaction would be clinically significant with the doses found in oral or topical progesterone supplements or non-prescription bioidentical products.

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General ...Overall, prescription forms of progesterone are generally well tolerated when used as prescribed. It is unclear how the progesterone found in supplemental or non-prescription bioidentical hormone products may alter the occurrence and likelihood of these adverse effects.
Most Common Adverse Effects:
Orally: Acne, allergic skin rash, altered menstrual cycles, appetite changes, breast discomfort, breast enlargement, depression, fatigue, fever, fluid retention, gastrointestinal disturbances, headache, insomnia, irregular bleeding, premenstrual syndrome (PMS)-like symptoms, and weight gain.
Topically: Vaginal spotting.

Dermatologic ...Orally, progesterone can cause fluid retention and edema, acne, allergic skin rashes, and hives (506,1224). When given intravenously, phlebitis has occurred at the injection site (93742,93748).

Endocrine ...Orally, progesterone can cause fever, breast discomfort or enlargement, and PMS-like symptoms (506,1224). Additionally, use of progesterone with estrogen is associated with greater risk of mammary gland hyperplasia (112975).

Gastrointestinal ...Orally, progesterone can cause gastrointestinal (GI) disturbances and changes in appetite (506,1224).

Genitourinary ...Orally, progesterone can cause altered menstrual cycles and irregular bleeding (506,1224,69986). Topically, progesterone can cause vaginal spotting (224).

Hepatic ...Progesterone can cause hepatotoxicity with elevated liver function tests (275). There is also some concern that autoimmune progesterone dermatitis (APD) can cause adverse hepatic effects, possibly due to the presence of progesterone receptors on cholangiocytes and hepatocytes. In one case report, a female patient treated with progesterone for menorrhagia for 1 week presented with APD characterized by cholestatic hepatitis and cutaneous inflammation (105866).

Immunologic ...Orally, progesterone can cause allergic skin rashes and hives (506,1224). In one case, a female patient treated with progesterone for menorrhagia presented after only 1 week with refractory jaundice due to cholestatic hepatitis and cutaneous inflammation in the form of erythematous, slightly blanchable plaques on the legs, upper arms, and abdomen. Autoimmune progesterone dermatitis (APD) was confirmed and localization of APD-related inflammation in the hepatobiliary system is thought to have been the reason for cholestatic hepatitis (105866).

Neurologic/CNS ...Orally, progesterone can cause fatigue, drowsiness or insomnia, and headache (506,1224,2032,69848,69986). Topically, progesterone can cause headache (108147). In one case report, a 37-year-old male crushed oral contraceptive pills containing progesterone and estrogen, mixed with water, and applied the mixture to the scalp twice daily for 3 months in an effort to stimulate hair growth. The patient developed a cerebral venous sinus thrombosis. His providers concluded this was most likely due to transdermal absorption of the hormones which may have been absorbed directly into the cerebral venous sinus. After 8 days of treatment in hospital with anti-coagulation therapy, the patient was discharged (112976). When given intramuscularly, progesterone can produce mild sedative effects or feelings of sluggishness (69815).

Psychiatric ...Orally, progesterone can cause depression or make depression worse (506,1224,69944).

Pulmonary/Respiratory ...There are case reports of hypersensitivity, resulting in pulmonary compromise, to the oil vehicle in progesterone-in-oil products (69847,69886).

Other ...Orally, progesterone can cause weight gain (506,1224).

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