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Gabapentin, Estrogen and placebo administration
This is a research combination of gabapentin (a gabapentinoid that modulates calcium channels) and estrogen (a hormone replacement therapy) tested together, likely to evaluate synergistic effects on vasomotor symptoms or neuropathic pain in menopausal women.
Gabapentin, in combination with estrogen and placebo, is a marketed product developed by the University of Rochester. The key composition patent expires in 2028, providing a period of exclusivity and potential revenue protection. The primary risk is the lack of clear primary indication and key trial results, which may limit its market adoption and competitive positioning.
At a glance
| Generic name | Gabapentin, Estrogen and placebo administration |
|---|---|
| Sponsor | University of Rochester |
| Drug class | Combination therapy (gabapentinoid + hormone replacement therapy) |
| Target | Voltage-gated calcium channel (alpha-2-delta subunit) for gabapentin; estrogen receptor for estrogen |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Menopause |
| Phase | FDA-approved |
Mechanism of action
Gabapentin reduces neuronal excitability by binding to the alpha-2-delta subunit of voltage-gated calcium channels, thereby reducing neurotransmitter release. Estrogen provides hormonal replacement to address menopausal symptoms. The combination is being studied to determine whether gabapentin enhances estrogen's efficacy or provides additional benefit for hot flashes and related symptoms in postmenopausal women.
Approved indications
- Vasomotor symptoms (hot flashes) in menopausal women
- Neuropathic pain in menopausal women (investigational)
Common side effects
- Dizziness
- Somnolence
- Peripheral edema
- Headache
- Breast tenderness (estrogen-related)
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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