Eating DisordersPhase 2REACTNCT03740204
The Role of Estrogen in the Neurobiology of Eating Disorders
A Phase 2 study testing 17-β estradiol transdermal patches and Micronized progesterone 200 MG in people with Eating Disorders and Hypoestrogenemia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme… Read more about this study
- Who is it for?
- Ages 14 to 35 years, women only
- Conditions the study is for
- Eating Disorders, Hypoestrogenemia
- What is being tested?
- 17-β estradiol transdermal patches and Micronized progesterone 200 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- 14-35 years
- Bone age ≥13.5 years (applicable only for participants <16 years)
- Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
- Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at >15 years if premenarchal or low estradiol levels evaluated by the study physician
- Low or normal weight defined by a body mass index that is <85th percentile for 14-18 year olds and a body mass index <25 kg/m2 for adults
Who cannot join
- Suicidal ideation where outpatient treatment is determined unsafe by study clinician
- Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
- Medications that contain estrogen ± progesterone within the past 3 months
- Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor
- Neurological or psychiatric disorders that may impact neural circuitry of interest
- Lifetime history of seizure disorder or electroconvulsive therapy
Show all 10Show fewer
- Pregnancy/breastfeeding
- Gastrointestinal tract surgery
- Contraindications to estrogen use
- Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
- Conditions
- Eating Disorders, Hypoestrogenemia
- Being tested
- 17-β estradiol transdermal patches, Placebo Patch, Micronized progesterone 200 MG, Placebo Pill.
- Keywords
- Adolescent, Amenorrhea, Anorexia Nervosa, Cognitive Flexibility, Dietary Restriction, Eating Disorders, Estrogen, Excessive Exercise, Females, Hypoestrogenemia, Reward
- Medical subject headings
- Feeding and Eating Disorders, Amenorrhea, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-β estradiol transdermal patchesDrug
17-β estradiol transdermal patches (100 mcg 17-β estradiol/day)
Placebo PatchDrug
Placebo patch
Micronized progesterone 200 MGDrug
Cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)- administered to those randomized to the transdermal estradiol patch for endometrial protection
Placebo Pill.Other
Administered to those receiving the placebo patch to maintain blinding
| Study group | Role | What they receive |
|---|---|---|
| 17-β estradiol with cyclic progesterone | Experimental | Not described Receives: Drug: 17-β estradiol transdermal patches; Drug: Micronized progesterone 200 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Patch; Other: Placebo Pill. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo
The Inhibition-Switching component of the D-KEFS CWIT simultaneously assesses verbal inhibition (suppressing the automatic urge to read the text) and cognitive flexibility/set-shifting (alternating rules on demand). Participants name the color of words representing colors printed in dissonant ink colors (e.g., the word "blue" in red ink). However, if words are framed by a box, they will be instructed to read the word instead. Within-condition scores are calculated by extracting two types of data: completion time and error metrics. The raw time is converted into an age-adjusted scaled score based on national normative data (Mean 10, SD 3). Uncorrected and self-corrected errors are tallied; total error counts are converted to a cumulative scaled score (Mean 10, SD 3). Total scaled scores range from 1-19 (0.1-99.9th percentile), with lower scores indicating clinically significant impairment and higher scores indicating superior performance.
Measured: Baseline to 8 weeks
Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score with 17-β estradiol versus placebo
The TEPS Consummatory Pleasure scale specifically captures sensory, physical, or immediate emotional gratification. It consists of 8 self-report items out of the 18 total items on the TEPS scale. Participants rate each of the 8 consummatory items using a 6-point Likert scale. To generate the final Consummatory Pleasure score, the raw values of the 8 items are summed and then averaged. The final score ranges between 1.0 and 6.0 range. Higher scores indicate greater capacity for pleasure. Lower scores indicate anhedonic traits.
Measured: Baseline to 8 weeks
Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placebo
In this computerized task/verbal administration of the MCQ, we assess an individual's extent of discounting the value of future rewards with increasing delay to reward receipt. Subjects will make 27 binary choices between smaller immediate and larger delayed monetary rewards of varying value and delay to reward receipt. From their responses, their Delay Discounting Parameter k is Calculated. The parameter k serves as a direct proxy for behavioral impulsivity and delay tolerance. In the standard MCQ-27, the derived k values range from roughly 0.00016 (highly patient; willing to wait months for a marginally larger reward) to 0.25 (highly impulsive; completely unwilling to wait). Raw k values are heavily skewed to the right and violate normal distribution assumptions required for parametric statistics; thus, raw k parameters are normalized using a log-transformation (natural log ln) before running inferential statistics.
Measured: Baseline to 8 weeks
Change in Eating Disorder Inventory-3 (EDI-3) Body Dissatisfaction score with 17-β estradiol versus placebo
The Body Dissatisfaction (BD) consists of 10 self-report items out of the 91 total items on the EDI-3, isolating the perceptual-affective component of body image disturbance. Participants rate each of the 10 items on a 6-point Likert scale. Total raw scores range from 0-36. Higher values indicate more pronounced body dissatisfaction/worse outcome.
Measured: Baseline to 12 weeks
Change in EDI-3 Drive for Thinness score with 17-β estradiol versus placebo
The Drive for Thinness (DT) scale consists of 7 self-report items out of the 91 total items on the EDI-3, isolating the obsessive preoccupation with weight, restrictive dieting, extreme desire to be thinner, and a psychological terror or intense fear of weight gain. Participants rate each of the 7 items on a 6-point Likert scale. Total raw scores range from 0-28. Higher values indicate more pronounced drive for thinness/worse outcome.
Measured: Baseline to 12 weeks
Secondary outcomes (5)
Change in functional magnetic resonance imaging (fMRI) activation of the dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) during a task switching paradigm with 17-β estradiol versus placebo
Measured: Baseline to 8 weeks
Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo
Measured: Baseline to 8 weeks
Change in fMRI activation of the VMPFC and ventral striatum during delay discounting with 17-β estradiol versus placebo
Measured: Baseline to 8 weeks
Change in the Eating Disorder Examination (EDE) Dietary Restraint subscale with 17-β estradiol versus placebo
The Dietary Restraint subscale consists of 5 items of the total 22 items rated on a forced-choice 7-point Likert scale ranging from 0 to 6 (0 = 0 days; 1 = 1-5 days; 2 = 6-12 days; 3 = 13-15 days; 4 = 16-22 days; 5 = 23-27 days; 6 = 28 days), targeting behavioral intentions and explicit attempts to restrict caloric intake over the past 28 days. Total score for the subscale is calculated by taking the average of the 5 constituent item scores. Total scores range from 0-6. Higher values indicate more pronounced dietary restraint/worse outcome.
Measured: Baseline to 12 weeks
Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo
The 4-day food diary (4DFR) captures detailed self-report food intake and includes 3 weekdays and 1 weekend day. Records will be analyzed by dieticians in the Clinical Research Center using NDS-R software v2008 (Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN. The mean caloric intake over 4 days was calculated by summing the caloric intake each day of the 4 days and taking the average.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start13 Jun 2019
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Madhusmita Misra, Massachusetts General Hospital
- Investigators
- Madhusmita Misra, M.D., M.P.H., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740204
- Sponsor's protocol ID
- 2018P002915
- Other IDs
- 1R01MH116205
- Acronym
- REACT
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2018
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Breithaupt L, Slattery M, Lauze M, Petterway F, Lindman L, Cravitz M, Naticchia S, Seenivasa S, Powers M, Javaras KN, Alperovitz DJ, Halperin J, Dechant E, Thomas JJ, Lawson EA, Lee H, Pizzagalli DA, Romer AL, Kumar P, Plessow F, Misra M, Eddy KT. Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on cognitive flexibility and reward processing. Contemp Clin Trials. 2025 Jul;154:107924. doi: 10.1016/j.cct.2025.107924. Epub 2025 Apr 26.
PubMed 40294815
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders
- ClinicalTrials.gov ID
- NCT03740204
- Acronym / sponsor ID
- REACT / 2018P002915
- Conditions
- Eating Disorders, Hypoestrogenemia
- Keywords
- Adolescent, Amenorrhea, Anorexia Nervosa, Cognitive Flexibility, Dietary Restriction, Eating Disorders, Estrogen, Excessive Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17-β estradiol with cyclic progesterone | Experimental | Drug: 17-β estradiol transdermal patches, Drug: Micronized progesterone 200 MG |
| Placebo | Placebo comparator | Drug: Placebo Patch, Other: Placebo Pill. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female
- 14-35 years
- Bone age ≥13.5 years (applicable only for participants <16 years)
- Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
- Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at >15 years if premenarchal or low estradiol levels evaluated by the study physician
Key exclusion criteria (10 listed)
- Suicidal ideation where outpatient treatment is determined unsafe by study clinician
- Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
- Medications that contain estrogen ± progesterone within the past 3 months
- Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor
- Neurological or psychiatric disorders that may impact neural circuitry of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17-β estradiol transdermal patches17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) | Drug | 17-β estradiol with cyclic progesterone |
| Placebo PatchPlacebo patch | Drug | Placebo |
| Micronized progesterone 200 MGCyclic progesterone (200 mg micronized progesterone daily for 12 days every month)- administered to those randomized to the transdermal estradiol patch for endometrial protection | Drug | 17-β estradiol with cyclic progesterone |
| Placebo Pill.Administered to those receiving the placebo patch to maintain blinding | Other | Placebo |
Primary outcome
Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
The Inhibition-Switching component of the D-KEFS CWIT simultaneously assesses verbal inhibition (suppressing the automatic urge to read the text) and cognitive flexibility/set-shifting (alternating rules on demand). Participants name the color of words representing colors printed in dissonant ink colors (e.g., the word "blue" in red ink). However, if words are framed by a box, they will be instructed to read the word instead. Within-condition scores are calculated by extracting two types of data: completion time and error metrics. The raw time is converted into an age-adjusted scaled score based on national normative data (Mean 10, SD 3). Uncorrected and self-corrected errors are tallied; total error counts are converted to a cumulative scaled score (Mean 10, SD 3). Total scaled scores range from 1-19 (0.1-99.9th percentile), with lower scores indicating clinically significant impairment and higher scores indicating superior performance.
Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
The TEPS Consummatory Pleasure scale specifically captures sensory, physical, or immediate emotional gratification. It consists of 8 self-report items out of the 18 total items on the TEPS scale. Participants rate each of the 8 consummatory items using a 6-point Likert scale. To generate the final Consummatory Pleasure score, the raw values of the 8 items are summed and then averaged. The final score ranges between 1.0 and 6.0 range. Higher scores indicate greater capacity for pleasure. Lower scores indicate anhedonic traits.
Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
In this computerized task/verbal administration of the MCQ, we assess an individual's extent of discounting the value of future rewards with increasing delay to reward receipt. Subjects will make 27 binary choices between smaller immediate and larger delayed monetary rewards of varying value and delay to reward receipt. From their responses, their Delay Discounting Parameter k is Calculated. The parameter k serves as a direct proxy for behavioral impulsivity and delay tolerance. In the standard MCQ-27, the derived k values range from roughly 0.00016 (highly patient; willing to wait months for a marginally larger reward) to 0.25 (highly impulsive; completely unwilling to wait). Raw k values are heavily skewed to the right and violate normal distribution assumptions required for parametric statistics; thus, raw k parameters are normalized using a log-transformation (natural log ln) before running inferential statistics.
Change in Eating Disorder Inventory-3 (EDI-3) Body Dissatisfaction score with 17-β estradiol versus placebo
Time frame: Baseline to 12 weeks
The Body Dissatisfaction (BD) consists of 10 self-report items out of the 91 total items on the EDI-3, isolating the perceptual-affective component of body image disturbance. Participants rate each of the 10 items on a 6-point Likert scale. Total raw scores range from 0-36. Higher values indicate more pronounced body dissatisfaction/worse outcome.
Change in EDI-3 Drive for Thinness score with 17-β estradiol versus placebo
Time frame: Baseline to 12 weeks
The Drive for Thinness (DT) scale consists of 7 self-report items out of the 91 total items on the EDI-3, isolating the obsessive preoccupation with weight, restrictive dieting, extreme desire to be thinner, and a psychological terror or intense fear of weight gain. Participants rate each of the 7 items on a 6-point Likert scale. Total raw scores range from 0-28. Higher values indicate more pronounced drive for thinness/worse outcome.
5 secondary outcomes
Change in functional magnetic resonance imaging (fMRI) activation of the dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) during a task switching paradigm with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
Change in fMRI activation of the VMPFC and ventral striatum during delay discounting with 17-β estradiol versus placebo
Time frame: Baseline to 8 weeks
Change in the Eating Disorder Examination (EDE) Dietary Restraint subscale with 17-β estradiol versus placebo
Time frame: Baseline to 12 weeks
Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 40294815Breithaupt L, Slattery M, Lauze M, Petterway F, Lindman L, Cravitz M, Naticchia S, Seenivasa S, Powers M, Javaras KN, Alperovitz DJ, Halperin J, Dechant E, Thomas JJ, Lawson EA, Lee H, Pizzagalli DA, Romer AL, Kumar P, Plessow F, Misra M, Eddy KT. Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on cognitive flexibility and reward processing. Contemp Clin Trials. 2025 Jul;154:107924. doi: 10.1016/j.cct.2025.107924. Epub 2025 Apr 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhusmita Misra, M.D., M.P.H. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 17-β estradiol transdermal patches and Micronized progesterone 200 MG in people with Eating Disorders and Hypoestrogenemia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo (time frame: Baseline to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.