Duphaston Cannot Be Used as a Vaginal Suppository
Duphaston (dydrogesterone) is formulated exclusively as an oral tablet and should not be used as a vaginal suppository. The medication is designed for oral administration only, and there is no evidence supporting its safety, efficacy, or appropriate dosing when used vaginally.
Why Vaginal Use Is Not Appropriate
Formulation and Approved Routes
- Dydrogesterone is manufactured as an oral retrosteroid with specific pharmacokinetic properties optimized for oral absorption 1
- The drug has been used clinically for over 40 years exclusively via the oral route 2
- No vaginal formulation of dydrogesterone exists, and oral tablets are not designed for vaginal insertion 3, 4
Clinical Evidence Supports Only Oral Administration
- Multiple randomized controlled trials have compared oral dydrogesterone with vaginal progesterone, consistently administering dydrogesterone orally at doses of 20-40 mg daily 3, 5, 4
- A large multicenter trial (n=1034) demonstrated that oral dydrogesterone 30 mg daily was non-inferior to vaginal progesterone gel for luteal phase support in IVF, with both medications administered via their intended routes 4
- Studies specifically highlight that oral dydrogesterone offers advantages over vaginal progesterone precisely because it avoids vaginal irritation, discharge, and local adverse effects associated with vaginal administration 3, 4
Appropriate Vaginal Progestogen Options
If Vaginal Administration Is Needed
When vaginal progestogen therapy is clinically indicated, use medications specifically formulated for vaginal use:
- Micronized progesterone vaginal gel (8%, 90 mg daily) or suppositories (400 mg twice daily) are the standard vaginal formulations 3, 5, 4
- Vaginal micronized progesterone 200 mg can be used for 12-14 days every 28 days when combined with transdermal estradiol 6
- These formulations are specifically designed for vaginal absorption and have established safety profiles 6
Hormone Replacement Therapy Context
- For endometrial protection in hormone replacement therapy, oral dydrogesterone is used at doses of 5-10 mg daily in continuous or sequential regimens 6
- If vaginal progestogen administration is preferred, use micronized progesterone 100-200 mg vaginally, not dydrogesterone 6
Critical Safety Considerations
Using oral tablets vaginally poses several risks:
- Unpredictable absorption and bioavailability
- Lack of dosing guidance for vaginal use
- Potential for inadequate endometrial protection if used for hormone replacement therapy
- Risk of local irritation from excipients not designed for vaginal mucosa
- No safety data supporting this off-label route
Always prescribe dydrogesterone orally as intended, or select an appropriate vaginal progestogen formulation if the vaginal route is specifically required 1, 3, 4.