Continuous Use of COCs

This study has been completed.

Sponsor:

Collaborator:

La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)

Information provided by (Responsible Party):

FHI 360

ClinicalTrials.gov Identifier:

NCT00570440

First received: December 10, 2007

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

October 28, 2011

Start Date ^ICMJE

August 2007

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

12 month cumulative COC discontinuation probabilities [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00570440 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Continuous Use of COCs

Official Title ^ICMJE

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Brief Summary

The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.

Detailed Description

Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Pregnancy Prevention

Intervention ^ICMJE

Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

3 visits - screening/enrollment, 6-months and 12 months

Study Arm (s)

Experimental: A
Intervention: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
Active Comparator: B
Intervention: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

362

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18-30
Currently has menstrual periods every 21-35 days
Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
Has signed the informed consent form
Has a negative urine pregnancy test at enrollment

Exclusion Criteria:

Has contraindications to COC use (see WHO MEC-3rd edition)
Is in any other research study
Has been pregnant in the past 3 months
Is breastfeeding or has breastfed in the past 3 months
Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)
Has had an injection of DMPA in the past 6 months
Has had an injection of NET-EN in the past 3 months
Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months
Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant:
- Pelvic infection treated with antibiotics
- Diagnosis of infertility
- Endometriosis

Gender

Female

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Dominican Republic, Nicaragua

Administrative Information

NCT Number ^ICMJE

NCT00570440

Other Study ID Numbers ^ICMJE

9964

Has Data Monitoring Committee

Not Provided

Responsible Party

FHI 360

Study Sponsor ^ICMJE

FHI 360

Collaborators ^ICMJE

La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)

Investigators ^ICMJE

Principal Investigator:

Kavita Nanda, MD, MHS

FHI 360

Information Provided By

FHI 360

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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