Contraceptive Hormones and Women With Cystic Fibrosis

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:

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 Overview

• Status: Terminated
• Conditions: Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception
• Intervention / Treatment: Other: Non-hormonal period; Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Pre-intervention; Patients will act as their own controls. Will have no hormones for 3 months	Other: Non-hormonal period
EXPERIMENTAL: Post-intervention; Ortho-cyclen (or a generic equivalent) which is Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg	Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg; Other Names: Mononessa; Sprintec; Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with contraception	Satisfaction overall	18 months
Exacerbation rate	Pseudomonas mucoidy conversion Quality of life Pulmonary function	18 months
Satisfaction with contraception	Satisfaction overall measured by a visual analog scale 0-10	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Mucus	Cervical mucus of CF patients relative to healthy controls	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (ESTIMATE): May 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Estrogens; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Estradiol; Ethinyl Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Norgestimate; Norgestrel
• Other Study ID Numbers: 819889