Trial Outcomes & Findings for Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women (NCT NCT03018366)

NCT ID: NCT03018366

Last Updated: 2025-03-13

Results Overview

Change in PAT measured as reactive hyperemia index (RHI) from baseline to week 12 on treatment or placebo. Reactive hyperemia index (RHI) is the post-to-pre occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone of the occluded arm calculated by taking the ratio of the pulse amplitude during the hyperemic phase (after a period of blood flow occlusion) to the baseline pulse amplitude. The values below \<1.67 are abnormal and suggest impaired endothelial function or endothelial dysfunction.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline, week 12 on trial
• Results posted on: 2025-03-13

Participant Flow

Participant milestones

Measure	17Beta Estradiol, Progesterone 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Overall Study STARTED	14	15
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Baseline characteristics by cohort

Measure	17Beta Estradiol, Progesterone n=14 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=15 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.	Total n=29 Participants Total of all reporting groups
Age, Continuous	27 years STANDARD_DEVIATION 6.7 • n=5 Participants	25.1 years STANDARD_DEVIATION 6.1 • n=7 Participants	26.0 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex/Gender, Customized Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	21.7 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	21.4 kg/m^2 STANDARD_DEVIATION 3.1 • n=7 Participants	21.5 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
Waist	27.1 inches STANDARD_DEVIATION 2.1 • n=5 Participants	27.1 inches STANDARD_DEVIATION 3.7 • n=7 Participants	27.1 inches STANDARD_DEVIATION 2.99 • n=5 Participants
Hip	34.0 inches STANDARD_DEVIATION 2.1 • n=5 Participants	34.4 inches STANDARD_DEVIATION 3.7 • n=7 Participants	34.2 inches STANDARD_DEVIATION 3.0 • n=5 Participants
Age at Menarche	13.1 years STANDARD_DEVIATION 1.8 • n=5 Participants	12.9 years STANDARD_DEVIATION 1.4 • n=7 Participants	12.96 years STANDARD_DEVIATION 1.6 • n=5 Participants
Serum Estradiol	24 pg/mL n=5 Participants	30 pg/mL n=7 Participants	25 pg/mL n=5 Participants

PRIMARY outcome

Timeframe: Baseline, week 12 on trial

Population: Our results represent the change (delta) in RHI after 12 week of treatment vs placebo

Change in PAT measured as reactive hyperemia index (RHI) from baseline to week 12 on treatment or placebo. Reactive hyperemia index (RHI) is the post-to-pre occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone of the occluded arm calculated by taking the ratio of the pulse amplitude during the hyperemic phase (after a period of blood flow occlusion) to the baseline pulse amplitude. The values below <1.67 are abnormal and suggest impaired endothelial function or endothelial dysfunction.

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry	0.20 change of RHI Standard Deviation 0.52	0.25 change of RHI Standard Deviation 0.64

SECONDARY outcome

Timeframe: Change in serum cortisol from baseline to week 12 on treatment or placebo

Change in serum cortisol from baseline to week 12 on treatment or placebo

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Serum Inflammatory Markers	-0.4 µg/dL Interval -4.57 to 1.7	3.1 µg/dL Interval 0.2 to 5.96

SECONDARY outcome

Timeframe: Serum estradiol levels after 12 week of treatment vs placebo

Week 12 serum estradiol levels

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Serum Estradiol Levels	108.0 pg/mL Interval 85.8 to 165.0	36.5 pg/mL Interval 16.7 to 51.2

SECONDARY outcome

Timeframe: Change in quality of life scores after 12 week of treatment vs placebo

Population: Our results represent the change (delta) in quality of life scores after 12 week of treatment vs placebo for MCS and PCS.

Short-Form Health Survey 12 (SF-12) was reported as the mental component score (MCS) and physical component score (PCS). Each scale ranges from 0 to 100. For both PCS and MCS, higher values represent better outcomes, indicating superior physical or mental health, respectively. Lower scores suggest poorer outcomes in the respective domains. Scores above 50 for either PCS or MCS are generally considered above the population average for health-related quality of life, as the scales are often normed to a mean of 50 with a standard deviation of 10 in general population studies. Scores below 50 suggest below-average physical or mental health, with the degree of deviation providing further insight into the severity of physical or mental health challenges.

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Quality of Life (Questionnaire) SF12-PCS	2.14 score on a scale Standard Deviation 7.97	-0.45 score on a scale Standard Deviation 4.44
Quality of Life (Questionnaire) SF12-MCS	1.83 score on a scale Standard Deviation 11.66	2.69 score on a scale Standard Deviation 5.99

SECONDARY outcome

Timeframe: Change in PHQ-9 Scores after 12 week of treatment vs placebo

Population: Our results report the change (delta) in PHQ-9 after 12 week of estrogen treatment vs placebo.

Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating greater severity of depressive symptoms.

Interpretation of Scores:

• 0-4: Minimal or no depression
• 5-9: Mild depression
• 10-14: Moderate depression
• 15-19: Moderately severe depression
• 20-27: Severe depression

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Depression	-0.67 score on a scale Standard Deviation 3.52	-0.08 score on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Insomnia score after 12 week of treatment vs placebo

Population: Our results report the change (delta) of the insomnia severity index after 12 week of estrogen treatment vs placebo

Change in Insomnia Severity Index after 12 week of treatment vs placebo. Insomnia Severity Index (ISI) total score ranges from 0 to 28.

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Change in Insomnia Severity Index After 12 Week of Treatment vs Placebo	8.0 score on a scale Standard Deviation 5.7	3.9 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Change in Anxiety Scores after 12 week of treatment vs placebo

Population: Our results report the change (delta) in Anxiety Scores after 12 week of estrogen treatment vs placebo

Overall Anxiety Severity and Impairment Scale (OASIS) total score ranges from 0 to 20, with each of the 5 items scored on a scale of 0 (no anxiety or impairment) to 4 (extreme anxiety or impairment). Higher scores indicate greater severity and functional impairment related to anxiety.

The OASIS scores can be categorized as follows:

• 0-4: Minimal or no anxiety
• 5-9: Mild anxiety
• 10-14: Moderate anxiety with some functional impairment
• 15-20: Severe anxiety with significant functional impairment.

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Anxiety	-0.31 score on a scale Standard Deviation 3.3	-0.54 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Change in stress scores after 12 week of treatment vs placebo

Population: Our results indicate the change (delta) in stress scores after 12 week of estrogen treatment vs placebo.

Cohen Perceived Stress Scale (PSS) ranges from 0 to 40, with each of the 10 items scored on a scale of 0 (never) to 4 (very often). Higher scores reflect higher levels of perceived stress.

The PSS scores can be categorized as follows:

• 0-13: Low perceived stress
• 14-26: Moderate perceived stress
• 27-40: High perceived stress

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Stress	-0.49 score on a scale Standard Deviation 3.69	-0.46 score on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: change in estradiol after 12 week of treatment vs placebo

Change from Baseline to week 12 serum estradiol levels

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Change in Serum Estradiol Levels	84 pg/mL Interval 44.3 to 144.8	-4.7 pg/mL Interval -14.6 to 4.25

SECONDARY outcome

Timeframe: Change in serum hsCRP from baseline to week 12 on treatment or placebo

Change in serum hsCRP from baseline to week 12 on treatment or placebo

Outcome measures

Measure	17Beta Estradiol, Progesterone n=12 Participants 17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product 17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides. Progesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.	Transdermal Placebo Patch, Placebo Pill n=12 Participants Placebo Transdermal Patch, Placebo Pill Transdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides. Placebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Serum Inflammatory Markers	0.0857 mg/L Interval 0.017 to 0.174	0.0322 mg/L Interval -0.00021 to 0.172

Adverse Events

17Beta Estradiol, Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transdermal Placebo Patch, Placebo Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chrisandra Shufelt

Mayo Clinic

Phone: 904-953-7224

Email: shufelt.chrisandra@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place