The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
Public ClinicalTrials.gov record NCT03003949. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Menopause Transition: Estrogen Variability, HPA Axis and Affective Symptoms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.
Study identification
- NCT ID
- NCT03003949
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Interventions
- Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release Drug
- Placebo Patch Drug
- Progesterone Capsule Drug
- Placebo Oral Capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 45 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2017
- Primary completion
- May 9, 2020
- Completion
- May 9, 2020
- Last update posted
- Mar 25, 2021
2017 – 2020
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UNC SHARRP Lab | Chapel Hill | North Carolina | 27517 | — |
| Susan Girdler, PhD, Principal Investigator | Chapel Hill | North Carolina | 27599 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03003949, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 25, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03003949 live on ClinicalTrials.gov.