NCT00204451

Brief Summary

The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

First QC Date

September 12, 2005

Last Update Submit

November 23, 2016

Conditions

Contraception

Keywords

emergency contraceptionfollicleovulationblood pressureFertility ControlInhibition of fertilization

Outcome Measures

Primary Outcomes (3)

  • follicle development

  • ovulation status

  • peripheral blood pressure

Secondary Outcomes (1)

  • endometrial development

Interventions

0.75 levonorgestrelDRUG
50 mg ethinyl estradiol/0.5 mg levonorgestrelDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female volunteers of childbearing potential;
  • Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
  • Age between 18 and 40 years old;
  • Normal body mass index (18-38);
  • Has signed informed consent form; and
  • Is in good health as confirmed by medical history, physical examination.

You may not qualify if:

  • A positive pregnancy test will automatically exclude the volunteer from participation in this study.
  • Any contraindication for oral contraception use;
  • Irregular menstrual cycles;
  • Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
  • Pregnancy (suspected or diagnosed) or lactation;
  • History or suspicion of drug or alcohol abuse;
  • Participation in an investigational drug trial within the 30 days prior to selection;
  • Exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
  • history of, or actual, thrombophlebitis or thromboembolic disorders.
  • history of, or actual, cerebrovascular disorders.
  • history of, or actual, myocardial infarction or coronary artery disease.
  • acute liver disease.
  • history of, or actual, benign or malignant liver tumors.
  • history of, or suspected, carcinoma of the breast.
  • known, or suspected, estrogen-dependent neoplasia.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ob-Gyn Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (2)

  • Pierson RA, Archer DF, Moreau M, Shangold GA, Fisher AC, Creasy GW. Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error. Fertil Steril. 2003 Jul;80(1):34-42. doi: 10.1016/s0015-0282(03)00556-9.

    PMID: 12849799BACKGROUND

  • Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.

    PMID: 12849812BACKGROUND

Study Officials

  • Roger A Pierson, MS PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Salma T Hanna, MD PhD

    University of Saskatchewan

    STUDY DIRECTOR

  • Olufemi A Olatunbosun, MD

    University of Saskatchewan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., FEAS, FCAHS, MS

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2005

Study Completion

June 1, 2006

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

CA(1)