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Side effects including weight gain, hirsutism, acne, headache, nausea, and vomiting all did not appear to increase in incidence and no "disturbing side effects" were noted in any of the women. [49] [50] Another study of 5 mg/day norethisterone in 132 women also made no mention of androgenic side effects. [51]
In terms of dosage equivalence, norethisterone and NETA are typically used at respective dosages of 0.35 mg/day and 0.6 mg/day as progestogen-only contraceptives, and at respective dosages of 0.5–1 mg/day and 1–1.5 mg/day in combination with ethinylestradiol in combined oral contraceptives. [8]
NETE is a prodrug of norethisterone in the body. [13] Upon reaching circulation, it is rapidly converted into norethisterone by esterases.Hence, as a prodrug of norethisterone, NETE has essentially the same effects as norethisterone, acting as a potent progestogen with additional weak androgenic and estrogenic activity (the latter via its metabolite ethinylestradiol). [14]
The most common side effects of the medication include hot flushes, excessive sweating or night sweats, uterine bleeding, hair loss or thinning, and decreased interest in sex. [8] The medication was approved for medical use in the United States in May 2021, [8] [11] [12] and in the European Union in July 2021. [9]
Side effects can include nausea, headache, blood clots, breast pain, depression, and liver problems. [2] Use is not recommended during pregnancy, the initial three weeks after childbirth, and in those at high risk of blood clots. [2] [4] It, however, may be started immediately after a miscarriage or abortion. [4]
The half-progestin-dose formulation of estradiol valerate/norethisterone enantate (5 mg / 25 mg) is also known as HRP-103 and the half-progestin-dose formulation of estradiol cypionate/medroxyprogesterone acetate (5 mg / 12.5 mg) is also known as HRP-113. [63] The following are CICs that have never been marketed:
Hormone levels following a single intramuscular injection of EV/NETE (5 mg/50 mg) in healthy young men. [9] Testosterone levels were maximally suppressed by about 94%, to ~30 ng/dL, when measured at day 7. [9] EV/NETE is a combination of EV, an estrogen, and NETE, a progestogen with weak androgenic activity.
In the United States, progestogen-only pills are available in 350-μg Norethisterone, 4-mg Drospirenone and Norgestrel 0.075-mg formulations. [18] Norgestrel is FDA-approved for over-the-counter availability, [19] and Norethindrone and Drospirenone are available by prescription.