AmenorrheaNCT00589654
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
An observational study of Amenorrhea and Menstrual Cycle, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Amenorrhea, Menstrual Cycle, Breast Cancer
- What is being tested?
- Questionnaire
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Stage 1-3 breast cancer patients 18-45 years of age will be identified. Those with normal menstrual cycles will be eligible.
Who may be able to join
- Non-institutional (community dwelling) woman of any race
- Between 18-45 years at the first screening visit
- Have regular menstrual cycles
- Diagnosed with invasive breast cancer stage I, II, III within the previous eight months
- Have physician agreement for patient participation
Who cannot join
- No menstrual bleeding cycles
- Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance
- Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer)
- Stage IV breast malignancy
- Residency outside United States
- No telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.
- Conditions
- Amenorrhea, Menstrual Cycle, Breast Cancer
- Being tested
- Questionnaire
- Keywords
- amenorrhea, menstrual cycle, Breast cancer, questionnaire, 97-127
- Medical subject headings
- Amenorrhea, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.
Measured: Conclusion of the study
Secondary outcomes (1)
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
Measured: Conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startDec 1997
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy-Ann Moo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589654
- Sponsor's protocol ID
- 97-127
- Other IDs
- DAMD17966292
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2007
- Last updated
- 26 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
- ClinicalTrials.gov ID
- NCT00589654
- Acronym / sponsor ID
- 97-127
- Conditions
- Amenorrhea, Menstrual Cycle, Breast Cancer
- Keywords
- amenorrhea, menstrual cycle, Breast cancer, questionnaire, 97-127
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 1997
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2008 (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.
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Stage 1-3 breast cancer patients 18-45 years of age will be identified. Those with normal menstrual cycles will be eligible.
Key inclusion criteria (5 listed)
- Non-institutional (community dwelling) woman of any race
- Between 18-45 years at the first screening visit
- Have regular menstrual cycles
- Diagnosed with invasive breast cancer stage I, II, III within the previous eight months
- Have physician agreement for patient participation
Key exclusion criteria (6 listed)
- No menstrual bleeding cycles
- Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance
- Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer)
- Stage IV breast malignancy
- Residency outside United States
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 |
|---|---|---|
| QuestionnaireData collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants. | Other | 1 |
Primary outcome
The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.
Time frame: Conclusion of the study
1 secondary outcome
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
Time frame: Conclusion of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Amenorrhea
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Observation of Environment and Reproductive-Endocrine Effects
Hypogonadism, Hypergonadism
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.
Tracy-Ann Moo, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amenorrhea and Menstrual Cycle, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance. (time frame: Conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.