Progesterone

Progesterone, Natural (OTC)

• Classes: Women’s Health, Herbals

progesterone intravaginal gel (Rx)

• Classes: Progestins; 
• Vaginal Preparations, Other

progesterone micronized (Rx)

• Classes: Progestins

Naturally occurring progestin administered orally,vaginally, and parenterally
Used to treat amenorrhea and abnormal uterine bleeding in women, and to prevent endometrial hyperplasia in postmenopausal women taking estrogen therapy, and off-label for premenstrual dysphoric disorder (PMDD)
Also used to prevent early pregnancy failure in women with corpus luteum insufficiency and to reduce the risk for preterm birth in women with single gestation pregnancy and a history of spontaneous preterm delivery

• Vaginal spotting
• Rash
• Edema
• Breast enlargement (40%)
• Breast tenderness (27%)
• Somnolence (27%)
• Cramps (15-26%)
• Mood swings (22-23%)
• Nausea (6-22%)
• Depression (11-19%)
• Dizziness (15-24%)
• Sleep disorder (18%)
• Perineal pain (17%)
• Nervousness (16%)
• Urinary difficulties (11%)
• Musculoskeletal pain (12%)
• Headache (13%)
• Breast pain (13%)
• Abdominal pain (5-12%)
• Headache (10-31%)
• Breast tenderness (16-27%)
• Dizziness (15-24%)
• Abdominal pain (10-20%)
• Depression (19%)
• Breast pain (6-16%)
• Viral disease (7-12%)
• Fatigue (8-9%)
• Nausea (8%)
• Mood swings (6%)

Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses; no adequate evidence is available to show that they are effective for this purpose

Caution in patients with family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy).

The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis); should any of these occur or be suspected, the drug should be discontinued immediately

The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear

Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery.

Discontinue 4 weeks before major surgery or prolonged immobilization. Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted).

Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk. Woman’s risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity.

Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer.; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk; increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use.

Do not use other intravaginal meds 6 hr before or after progesterone vaginal

Pregnancy Category: avoid use

Lactation: N/A

Pregnancy Category: avoid use

Lactation: N/A

Pregnancy Category: B

Lactation: Possibly safe; use caution