Cystic Fibrosis Exacerbations While on and Off Hormonal ContraceptionPhase 1NCT02144246
Contraceptive Hormones and Women With Cystic Fibrosis
A Phase 1 study testing Non-hormonal period and Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg in people with Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception, run by University of Pennsylvania at 1 site in United States.
Trial summary
Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception
- What is being tested?
- Non-hormonal period and Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2015
- Phase
- Phase 1
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles
Who cannot join
- pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations.
We hypothesize:
Read more
1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit,
1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception,
1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and
1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception.
Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls.
We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
- Being tested
- Non-hormonal period, Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-hormonal periodOther
Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mgDrug
Also called Mononessa, Sprintec, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | Other | Patients will act as their own controls. Will have no hormones for 3 months Receives: Other: Non-hormonal period |
| Post-intervention | Experimental | Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg Receives: Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with contraception
Satisfaction overall
Measured: 18 months
Exacerbation rate
Pseudomonas mucoidy conversion Quality of life Pulmonary function
Measured: 18 months
Satisfaction with contraception
Satisfaction overall measured by a visual analog scale 0-10
Measured: 18 months
Secondary outcomes (1)
Cervical Mucus
Cervical mucus of CF patients relative to healthy controls
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Exacerbations While on and Off Hormonal ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Courtney Schreiber, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144246
- Sponsor's protocol ID
- 819889
- Status last verified
- Jan 2016
- First submitted
- 19 May 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
- ClinicalTrials.gov ID
- NCT02144246
- Acronym / sponsor ID
- 819889
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- First posted
- 21 May 2014 (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.
Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations.
We hypothesize:
1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit,
1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception,
1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and
1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception.
Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls.
We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | Other | Other: Non-hormonal periodPatients will act as their own controls. Will have no hormones for 3 months |
| Post-intervention | Experimental | Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mgOrtho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles
Key exclusion criteria (1 listed)
- pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception
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 |
|---|---|---|
| Non-hormonal period | Other | Pre-intervention |
| Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mgAlso: Mononessa, Sprintec, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg | Drug | Post-intervention |
Primary outcome
Satisfaction with contraception
Time frame: 18 months
Satisfaction overall
Exacerbation rate
Time frame: 18 months
Pseudomonas mucoidy conversion Quality of life Pulmonary function
Satisfaction with contraception
Time frame: 18 months
Satisfaction overall measured by a visual analog scale 0-10
1 secondary outcome
Cervical Mucus
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-hormonal period and Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg in people with Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception, run by University of Pennsylvania 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Jan 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Satisfaction with contraception (time frame: 18 months). The study lists 3 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 8 Jan 2016.