Pharmacokinetics of allopregnanolone after multiple dose administration of progesterone in post-menopausal healthy volunteer women.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001102965

Enrollment

Registered

2020-10-23

Start date

2020-11-02

Completion date

2021-04-30

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Postpartum depression (PPD) is a severe disorder that adversely impacts both mothers and infants and is associated with significant morbidity and mortality. PPD’s pathophysiology may involve changes in perinatal hormones such as allopregnanolone (ALLO, an endogenous progesterone metabolite). Brexanolone (BREX) is a small molecule, neuroactive steroid GABAA receptor allosteric modulator consisting of synthetic ALLO and a solubilizing agent. In early 2019 BREX received FDA approval for the treatment of PPD. BREX is only available through a restricted program and is expensive. We explored whether ALLO concentrations could be increased via oral progesterone loading. This study will explore whether ALLO concentrations can be increased via oral progesterone loading in a cohort of post-menopausal women who are physiologically not producing endogenous progesterone

Interventions

Multiple rising dose study to measure plasma allopregnanolone concentrations after multiple doses of extended release progesterone tablets. Cohort 1 will take a 300mg dose twice on Day 1, once in the morning and afternoon, followed by a single 600mg dose in the morning on Day 2. Cohort 2 will take a 300mg dose once on Day 1, in the morning, 600 mg dose once on Day 1, in the afternoon, followed by a single 900mg dose in the morning on Day 2. Cohort 3 will take a 300mg dose once on Day 1, in the morning, 900 mg dose once on Day 1, in the afternoon, followed by a single 1200mg dose in the morning on Day 2. Adherence will be indirectly monitored by the serum levels testing of allopregnenolone. Participants can participate in only one of the 3 cohorts. Cohorts will start simultaneously.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

Healthy females; aged 20-60; weight at least 50kg, with a minimum BMI of 18. Participants will be POST menopausal as we are seeking healthy volunteers who are physiologically not producing endogenous progesterone.

Exclusion criteria

Severe or unstable medical conditions; regular use of alcohol/ recreational drugs.

Outcome results