Clinical trial NCT00570440: Continuous Use of COCs
Official title: Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
µg microgram
ULN upper limit of the normal range
WB Western Blot
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
First posted: 2007-12-11
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 12 month cumulative COC discontinuation probabilities
timeFrame: 12 months
Secondary outcomes:
measure: Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit
timeFrame: 12 months
Other outcomes:
Locations:
city: Ens. Luperon
country: Dominican Republic
facility: PROFAMILIA - Santo Domingo, Dominican Republic
state: Santo Domingo
city: Managua
country: Nicaragua
facility: PROFAMILIA - Managua, Nicaragua
Study officials:
affiliation: FHI 360
name: Kavita Nanda, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.