Disorder of Endocrine OvaryNCT01674426
Pathogenesis of Functional Hypothalamic Amenorrhea
A study testing Cognitive behavior therapy in people with Disorder of Endocrine Ovary and Hypersecretion; Cortisol, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance
- What is being tested?
- Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Aug 2003
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with functional hypothalamic amenorrhea
- day awake / night asleep schedule
Who cannot join
- eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
- weight loss greater than 10 pounds when amenorrhea developed
- running more than 10 miles per week or exercising more than 10 hours per week
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
Read the detailed description
The study enrollment was completed in 2003. The study results are being analyzed.
- Conditions
- Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance, Stress, Psychological
- Being tested
- Cognitive behavior therapy
- Keywords
- functional hypothalamic amenorrhea, stress induced anovulation
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
16 sessions of 45 minutes each to review stress management
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | Cognitive behavior therapy consisting of 16 sessions over 20 weeks Receives: Behavioral: Cognitive behavior therapy |
| observation | Placebo comparator | Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed Receives: Behavioral: Cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian function
The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function
Measured: Change before and after 20 weeks of CBT or observation
Secondary outcomes (1)
metabolism
The change in metabolism was assessed by measuring levels of cortisol, TSH, T4, free T4, T3, free T3, leptin in blood and by measuring weight before and after 20 weeks of CBT or observation
Measured: Change before and after 20 weeks of CBT or observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startNov 1997
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorder of Endocrine OvaryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Sarah Berga, University of Pittsburgh
- Investigators
- Sarah L Berga, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674426
- Sponsor's protocol ID
- MH50748
- Status last verified
- Jun 2017
- First submitted
- 14 Aug 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
PubMed 14556820Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086.
PubMed 28453773Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16.
PubMed 23507474
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Functional Hypothalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT01674426
- Acronym / sponsor ID
- MH50748
- Conditions
- Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance, Stress, Psychological
- Keywords
- functional hypothalamic amenorrhea, stress induced anovulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Nov 1997
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 28 Aug 2012 (estimated)
- 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 pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
Detailed description
The study enrollment was completed in 2003. The study results are being analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Behavioral: Cognitive behavior therapyCognitive behavior therapy consisting of 16 sessions over 20 weeks |
| observation | Placebo comparator | Behavioral: Cognitive behavior therapySubjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women with functional hypothalamic amenorrhea
- day awake / night asleep schedule
Key exclusion criteria (3 listed)
- eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
- weight loss greater than 10 pounds when amenorrhea developed
- running more than 10 miles per week or exercising more than 10 hours per week
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 |
|---|---|---|
| Cognitive behavior therapy16 sessions of 45 minutes each to review stress management | Behavioural | Cognitive behavior therapy, observation |
Primary outcome
ovarian function
Time frame: Change before and after 20 weeks of CBT or observation
The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function
1 secondary outcome
metabolism
Time frame: Change before and after 20 weeks of CBT or observation
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 2 Jul 2017.
- Results publication: PubMed 14556820Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
- Derived from this study: PubMed 28453773Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086.
- Derived from this study: PubMed 23507474Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16.
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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.
Sarah L Berga, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Disorder of Endocrine Ovary and Hypersecretion; Cortisol, run by University of Pittsburgh 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 2 inclusion and 3 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 2 Jul 2017. 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.
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?
ovarian function (time frame: Change before and after 20 weeks of CBT or observation). 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 NCT01674426, which also lists 3 linked publications.
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 2 Jul 2017.