Prometrium Appetite & Cravings Changes: What the Evidence Actually Shows

Does the label list appetite or cravings?

The label's 3-year placebo-controlled trial compared cyclic Prometrium 200 mg plus conjugated estrogens 0.625 mg (n=178) with placebo (n=174). Nausea and vomiting were reported by 8% versus 7% and abdominal bloating by 12% versus 5% [1]. None of those rows is appetite, hunger or cravings. A second trial, in 49 estrogen-primed women, compared Prometrium 400 mg (n=25) with placebo (n=24) and reported nausea 8% versus 0% and abdominal cramping 20% versus 13% [1].

Can the bloating numbers be pinned on progesterone?

No. In the larger trial the active arm also took conjugated estrogens 0.625 mg and the comparator took no hormones, so a gap between columns cannot be assigned to progesterone alone [1]. Prometrium is labeled for endometrial-hyperplasia prevention in postmenopausal women taking conjugated estrogens tablets and for secondary amenorrhea [1].

What the large trials measured instead

PEPI randomized 875 healthy postmenopausal women aged 45 to 64 in a 3-year double-blind trial with five arms, one of them conjugated equine estrogen 0.625 mg plus cyclic micronized progesterone 200 mg for 12 days a month [2]. Its primary endpoints were HDL cholesterol, systolic blood pressure, serum insulin and fibrinogen [2]. The companion symptom report found more breast discomfort with progestin-containing regimens (odds ratio 1.92 to 2.27) and fewer vasomotor symptoms on all active treatments (odds ratio 0.17 to 0.28) [3]. Neither report's abstract describes an appetite or food-craving result [2][3].

What the label warns about

The label directs a single daily dose at bedtime and states that Prometrium may cause transient dizziness and drowsiness and should be used with caution when driving a motor vehicle or operating machinery [1]. Peanut allergy is a labeled contraindication because the capsules contain peanut oil, along with abnormal genital bleeding of unknown cause, known or suspected breast cancer or a history of it, active or prior DVT or PE, active or prior arterial thromboembolic disease, and known liver dysfunction or disease [1].