Health TrialsbyHealthPanel

Progesterone in Gender Affirming Hormone Therapy Study

ConditionTransgender Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-60
SponsorEmory University

About this trial

This study aims to study the effects of Oral Progesterone in Transgender Women. The primary goal is to study the effect of progesterone on psychological distress and secondarily on sleep quality, breast size, quality of life and gender congruence and cardiovascular risk.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Peanut allergy

Liver disease (liver enzyme elevations and/or evidence of acute or chronic hepatitis). In our lab, the upper limit of normal for aspartate aminotransferase (AST) is 39, and the upper limit of normal for alanine aminotransferase (ALT) is 52.

Stage 4/5 chronic kidney disease

Congestive heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    The placebo will be nearly identical in size, color, and shape to micronized progesterone

  • Progesterone

    Drug

    Oral micronized progesterone 200 mg

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group APlacebo comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Psychological Distress

Kessler Psychological Distress Scale (K10) scale will be used to measure distress. This is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The numbers attached to the patients 10 responses are added up and the total score is the score on the Kessler Psychological Distress Scale (K10). Scores will range from 10 to 50. People seen in primary care who: * score under 20 are likely to be well * score 20-24 are likely to have a mild mental disorder * score 25-29 are likely to have moderate mental disorder * score 30 and over are likely to have a severe mental disorder

Time frame
Baseline, Month 6

Secondary outcomes

1

Effect of progesterone on breast development

Breast size will be measured using hemi-circumference. Hemi circumference will be measured as the medial breast infliction point, the most medial point of the breast across the nipple level to the lateral breast inflection point.

Time frame
Baseline, Month 6
2

Effect of progesterone on sleep quality

Sleep quality will be measured by having participants from both Group A and B take the 19 item Pittsburgh sleep index. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire that assesses sleep quality and disturbances over the past month. Each item is scored on a scale of 0-3, with 3 being the worst. The global score ranges from 0-21, with higher scores indicating worse sleep quality.

Time frame
Baseline, Month 6
3

Effect of progesterone on gender congruence

The gender Congruence and Life Satisfaction Scale (GCLS) will be used. It is a 38-item scale with each item scored on a 5-point scale. Items are scored on a 5-point scale (always = 1; never = 5). A higher score indicates a more positive outcome (higher gender congruence, better gender-related mental well-being, and better general life satisfaction).

Time frame
Baseline, Month 6
4

Effect of progesterone on cardiovascular risk

Change in lipid profile from baseline.

Time frame
Baseline, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Source ClinicalTrials.gov
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