Progesterone

DRUG INFORMATION

  ADULT
    - The dose of progesterone vaginal insert is 100 mg administered vaginally two or
      three times daily starting the day after oocyte retrieval and continuing for up to
      10 weeks total duration.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'dosage and administration', retrieved 2026-08-29
    - The appropriate dose of progesterone vaginal insert in this age group has not been
      determined ( 2.1 ). 2.1 General Dosing Information The dose of progesterone
      vaginal insert is 100 mg administered vaginally two or three times daily starting
      the day after oocyte retrieval and continuing for up to 10 weeks total duration.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'dosage and administration', retrieved 2026-08-29
    - The dose of progesterone vaginal insert is 100 mg administered vaginally two or
      three times daily starting the day after oocyte retrieval and continuing for up to
      10 weeks total duration. Efficacy in women 35 years of age and older has not been
      clearly established. The appropriate dose of progesterone vaginal insert in this
      age group has not been determined ( 2.1 ).
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - This drug is not intended for pediatric use and no clinical data have been
      collected in children. Therefore, the safety and effectiveness of progesterone
      vaginal insert in pediatric patients have not been established.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'pediatric use', retrieved 2026-08-29
    - The dose of progesterone vaginal insert is 100 mg administered vaginally two or
      three times daily starting the day after oocyte retrieval and continuing for up to
      10 weeks total duration. Efficacy in women 35 years of age and older has not been
      clearly established. The appropriate dose of progesterone vaginal insert in this
      age group has not been determined ( 2.1 ).
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'dosage and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for progesterone (PROGESTERONE
      VAGINAL INSERTS), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for progesterone (PROGESTERONE
      VAGINAL INSERTS), retrieved 2026-08-29

  PREGNANCY
    - Progesterone vaginal insert has been used to support embryo implantation and
      maintain clinical pregnancy in one clinical study.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'pregnancy', retrieved 2026-08-29
    - The live birth outcomes of these pregnancies were as follows: • Among the 404
      subjects treated with progesterone vaginal insert twice daily, 143 subjects had
      livebirths consisting of 85 singletons, 56 twins, and 2 triplets.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'pregnancy', retrieved 2026-08-29
    - In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an
      ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203
      livebirths). • Among the 404 subjects treated with progesterone vaginal insert
      three times daily, 155 subjects had livebirths consisting of 91 singletons, 60
      twins, and 4 triplets.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Detectable amounts of progesterone have been identified in the milk of nursing
      mothers.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'nursing mothers', retrieved 2026-08-29
    - The effect of this on the nursing infant has not been determined.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section
      'nursing mothers', retrieved 2026-08-29
    - For additional information on the pharmacology of progesterone vaginal insert and
      pregnancy outcome information [see Clinical Pharmacology ( 12 ) and Clinical
      Studies Sections ( 14 )] . 8.3 Nursing Mothers Detectable amounts of progesterone
      have been identified in the milk of nursing mothers.
      Source: US FDA label for progesterone (PROGESTERONE VAGINAL INSERTS), section 'use
      in specific populations', retrieved 2026-08-29