Novel Combined Oral Contraceptive Effective in Phase 3 Trial
Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters.
Women’s Health
Osphena Approved for Moderate to Severe Vaginal Dryness Due to Menopause
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness.
New HPV Screening Kit Allows Women to Test at Home
To obtain a kit, patients must first answer a few medical history questions to determine if they are appropriate candidates for at-home testing.
Finasteride Uses, Efficacy Examined in Female Patients
Off-label use has become more common in women for treatment of alopecia and hirsutism.
ACOG Updates Guidelines for Gestational HTN, Preeclampsia
Second bulletin provides recommendations for management of chronic hypertension in pregnancy
Women Fed Soy Formula as Infants More Likely to Experience Menstrual Pain
Researchers at the National Institute of Environmental Health Sciences (NIEHS), Vanderbilt University Medical Center, and the Henry Ford Health System analyzed patient data from African-American women aged 23 to 35 years (N=1553) who were participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF).
FDA Panel Votes on Postpartum Depression Treatment Zulresso
If approved, Zulresso would be the first drug approve for the treatment of postpartum depression.
Oral Contraceptives Recalled Due to Incorrect Dispenser Instructions
Without proper instructions for the correct use of the Veridate dispenser pack, the patient may take the pills in the wrong order or may take an inactive “reminder” pill vs an “active” pill.
Bijuva Approved for Moderate to Severe Vasomotor Symptoms Due to Menopause
Approval from the Food and Drug Administration (FDA) was supported by the Phase 3 Replenish trial which evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
FDA Approves Diagnostic Test to Help Determine Menopausal Status
The FDA’s marketing approval was supported by data from 690 women (aged 42 to 62 years) who were enrolled in the Study of Women’s Health Across the Nation.
