Contraceptive Hormones and Women With Cystic Fibrosis

University of Pennsylvania

Status and phase: Terminated; Phase 1

Conditions: Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception

Treatments: Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg; Other: Non-hormonal period

Study type: Interventional

Funder types: Other

Identifiers

NCT02144246

819889

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 2 patient groups

Pre-intervention

Other group

Description:

Patients will act as their own controls. Will have no hormones for 3 months

Treatment:

Other: Non-hormonal period

Post-intervention

Experimental group

Description:

Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

Treatment:

Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg