Pregnenolone: clinical trials recruiting now
3
Recruiting trials
6
Conditions studied
2
US states with sites
1
Countries
FDA drug label
- FDA-approved
- Yes. Pregnenolone appears in the FDA drug-label database. Marketed as Gynobalance.
- Drug class
- Estrogen; Progesterone; Androgen (FDA established pharmacologic class)
- Mechanism of action
- Estrogen Receptor Agonists; Androgen Receptor Agonists (as stated on the FDA label)
FDA-approved use
USES: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; for enhancing feelings of wellbeing, enhance calcium metabolism, and improving mental clarity.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-09-07 |
| Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. — Mylan Pharmaceuticals Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2017-01-30 |
| Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-12-26 |
| Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. — Noven Pharmaceuticals Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-04-16 |
| Failed Stability Specifications; out of specification for shear. — Noven Pharmaceuticals Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2021-07-30 |
Phase breakdown
Phase 2 2
Not applicable 1
Conditions being studied
| Condition | Trials |
|---|---|
| Depression · Pregnenolone for Depression | 3 |
| Anxiety | 2 |
| Anxiety Depression | 1 |
| Anxiety and Depression | 1 |
| HIV | 1 |
| Major Depressive Disorder | 1 |
Recruiting trials involving Pregnenolone
- A New Intervention to Improve Function in Veterans With Anxiety and Depression
- Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
- Study on Allopregnanolone and Depression in Women Across the Menopause Transition
Common questions
Is Pregnenolone FDA-approved?
Yes, marketed as Gynobalance.
How many recruiting trials involve Pregnenolone?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.