Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception Clinical Trial
Official title:
Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
| NCT number | NCT02144246 |
| Other study ID # | 819889 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 1 |
| First received | May 19, 2014 |
| Last updated | January 6, 2016 |
| Start date | May 2014 |
| Verified date | January 2016 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles Exclusion Criteria: - pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania | Society of Family Planning |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Satisfaction with contraception | Satisfaction overall | 18 months | No |
| Primary | Exacerbation rate | Pseudomonas mucoidy conversion Quality of life Pulmonary function | 18 months | No |
| Primary | Satisfaction with contraception | Satisfaction overall measured by a visual analog scale 0-10 | 18 months | No |
| Secondary | Cervical Mucus | Cervical mucus of CF patients relative to healthy controls | 3 months | No |