Continuous Use of COCs | NCT00570440

Studies
Continuous Use of COCs

NCT00570440

Sponsor

FHI 360

Status

Completed

Last Update Posted

Oct 31, 2011Estimated

Enrollment

362Estimated

Phase

Phase 4

Conditions

Pregnancy Prevention

Interventions

Oral contraceptives--ethinyl estradiol, levonorgestrel

Countries

Dominican Republic
Nicaragua

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 10, 2007

First Submission Date that Met QC Criteria

Dec 10, 2007

First Posted Date

Dec 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2011

Last Update Posted Date

Oct 31, 2011Estimated

Name	Class
La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)	OTHER

Description Module

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

Conditions Module

Conditions

Pregnancy Prevention

Keywords

AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU international units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
B	Active Comparator		Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral contraceptives--ethinyl estradiol, levonorgestrel	Drug	3 visits - screening/enrollment, 6-months and 12 months	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
12 month cumulative COC discontinuation probabilities		12 months

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kavita Nanda, MD, MHS	FHI 360	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
PROFAMILIA - Santo Domingo, Dominican Republic		Ens. Luperon	Santo Domingo Province		Dominican Republic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24785854	Derived	Nanda K, Lendvay A, Kwok C, Tolley E, Dube K, Brache V. Continuous compared with cyclic use of oral contraceptive pills in the Dominican Republic: a randomized controlled trial. Obstet Gynecol. 2014 May;123(5):1012-1022. doi: 10.1097/AOG.0000000000000235.

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

ID	Term
D004997	Ethinyl Estradiol
D016912	Levonorgestrel

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids