Cystic FibrosisMENSTRUALNCT04620096
MENstrual Symptom Tracking to Understand and Assess (Women) Living With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University of Washington at 1 site in United States.
Trial summary
Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women with CF have a lower life expectancy than men with CF. Despite these known differences, the link between CF symptom trends and the menstrual cycle remains critically understudied. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 22 Apr 2022
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Regularly menstruating women with Cystic Fibrosis
Who may be able to join
- Females with CF, ages > or = 18 and < 46 years
- Able to read, speak, and understand English
- Have regular menstrual cycles between 21 and 35 days
- If using oral contraceptive pills, patch, or vaginal ring, must have a monthly withdrawal bleed every 21-35 days
- If on a genetic modulator, must be on steady dose for at least 3 months
- Willing to document daily symptoms (or no symptoms) every day for up to four consecutive months
- Has a functioning smartphone app with capability to load a "period tracking" app or, if no smartphone, is willing to complete a paper diary and mail to research team monthly
- Currently resides within the United States
Who cannot join
- Not regularly menstruating or no regular withdrawal bleed every 21-35 days (with or without hormonal contraception use)
- Planning pregnancy at the start of, or any time during, the 3-month observation period
- Planning to use a hormonal IUD, subdermal contraceptive implant (such as Nexplanon), or injectable contraceptive (such as Depo-Provera) at the start of, or any time during, the 3-month observation period
- Women on the transplant list or what have had a lung transplant
Trial locations and contacts
1 site in 1 country.
About this study
Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women with CF have a lower life expectancy than men with CF. Despite these known differences, the link between CF symptom trends and the menstrual cycle remains critically understudied. To address this gap, this study will investigate changes in CF-specific symptoms among women with CF to evaluate whether and how they correlate with their menstrual cycle. Specifically, the investigators hope to examine whether CF-related symptoms change throughout the menstrual cycle, what the impact of those symptoms is on quality of life, and how feasible it is to use a period tracking app to track CF-related symptoms throughout the menstrual cycle. Investigators are asking women ages 18-45 with CF, who have regular menstrual cycles, to participate. Study procedures, including online surveys, period tracking, and interview, will take approximately 3 months.
Read the detailed description
To better understand the connection between cyclically driven hormone fluctuations and CF-related symptoms, the investigators propose an explanatory, sequential mixed methods study in which 80 menstruating women with CF will be asked to track their daily CF-related symptoms for three consecutive cycles. From this cohort, the investigators will ask up to 30 women with CF to participate in one semi-structured interview to gather information about the impact of cyclical CF symptoms upon women's daily lives and any strategies they use to manage them. This study uses innovative technology to track CF-specific symptoms with a smartphone app. The investigators' hypothesis is that subjective changes in clinical CF symptoms, including pulmonary and sinus (primary outcome), rheumatic, and gastrointestinal (secondary outcomes), will map onto the phases of the menstrual cycle and will be cyclical in nature; women will report alternative ways in which they manage their cyclical CF symptoms; and the period tracker app will be easy for women to use.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Menstrual Cycle
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change of Cystic Fibrosis-related pulmonary symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measured: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Average change of Cystic Fibrosis-related sinus symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measured: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Secondary outcomes (2)
Average change of Cystic Fibrosis-related rheumatic symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measured: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Average change of Cystic Fibrosis-related gastrointestinal symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measured: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jun 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, University of California, San Diego, Mount Sinai Hospital, New York
- Responsible party
- Principal investigator, Emily Godfrey, University of Washington
- Investigators
- Emily Godfrey, MD, MPH, Principal investigator, University of WashingtonSandy Sufian, PhD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620096
- Sponsor's protocol ID
- STUDY00009993
- Other IDs
- GODFRE20A0
- Acronym
- MENSTRUAL
- Status last verified
- May 2023
- First submitted
- 9 Oct 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MENstrual Symptom Tracking to Understand and Assess (Women) Living With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04620096
- Acronym / sponsor ID
- MENSTRUAL / STUDY00009993
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of California, San Diego, Mount Sinai Hospital, New York
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 6 Nov 2020 (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.
Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women with CF have a lower life expectancy than men with CF. Despite these known differences, the link between CF symptom trends and the menstrual cycle remains critically understudied. To address this gap, this study will investigate changes in CF-specific symptoms among women with CF to evaluate whether and how they correlate with their menstrual cycle. Specifically, the investigators hope to examine whether CF-related symptoms change throughout the menstrual cycle, what the impact of those symptoms is on quality of life, and how feasible it is to use a period tracking app to track CF-related symptoms throughout the menstrual cycle. Investigators are asking women ages 18-45 with CF, who have regular menstrual cycles, to participate. Study procedures, including online surveys, period tracking, and interview, will take approximately 3 months.
Detailed description
To better understand the connection between cyclically driven hormone fluctuations and CF-related symptoms, the investigators propose an explanatory, sequential mixed methods study in which 80 menstruating women with CF will be asked to track their daily CF-related symptoms for three consecutive cycles. From this cohort, the investigators will ask up to 30 women with CF to participate in one semi-structured interview to gather information about the impact of cyclical CF symptoms upon women's daily lives and any strategies they use to manage them. This study uses innovative technology to track CF-specific symptoms with a smartphone app. The investigators' hypothesis is that subjective changes in clinical CF symptoms, including pulmonary and sinus (primary outcome), rheumatic, and gastrointestinal (secondary outcomes), will map onto the phases of the menstrual cycle and will be cyclical in nature; women will report alternative ways in which they manage their cyclical CF symptoms; and the period tracker app will be easy for women to use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Regularly menstruating women with Cystic Fibrosis
Key inclusion criteria (8 listed)
- Females with CF, ages > or = 18 and < 46 years
- Able to read, speak, and understand English
- Have regular menstrual cycles between 21 and 35 days
- If using oral contraceptive pills, patch, or vaginal ring, must have a monthly withdrawal bleed every 21-35 days
- If on a genetic modulator, must be on steady dose for at least 3 months
Key exclusion criteria (4 listed)
- Not regularly menstruating or no regular withdrawal bleed every 21-35 days (with or without hormonal contraception use)
- Planning pregnancy at the start of, or any time during, the 3-month observation period
- Planning to use a hormonal IUD, subdermal contraceptive implant (such as Nexplanon), or injectable contraceptive (such as Depo-Provera) at the start of, or any time during, the 3-month observation period
- Women on the transplant list or what have had a lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average change of Cystic Fibrosis-related pulmonary symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Time frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Rating of Mild, Moderate, or Severe in the Clue smartphone app
Average change of Cystic Fibrosis-related sinus symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Time frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Rating of Mild, Moderate, or Severe in the Clue smartphone app
2 secondary outcomes
Average change of Cystic Fibrosis-related rheumatic symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Time frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
Average change of Cystic Fibrosis-related gastrointestinal symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal)
Time frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment
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 22 May 2023.
- Individual participant dataSharing planned: No
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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.
Emily Godfrey, MD, MPH principal investigator
University of Washington
Sandy Sufian, PhD, MPH principal investigator
University of Illinois Chicago
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 Cystic Fibrosis, run by University of Washington 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 8 inclusion and 4 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 22 May 2023. 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?
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?
Average change of Cystic Fibrosis-related pulmonary symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal) (time frame: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollment). The study lists 2 primary outcomes in all. 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 22 May 2023.