NCT00204438

Brief Summary

We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2002

Shorter than P25 for not_applicable

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

February 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.8 years 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
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

female contraceptionoral contraceptiveemergency contraceptiveovaryfollicleovulation

Outcome Measures

Primary Outcomes (4)

  • follicle growth

  • ovulation/anovulation

  • estradiol concentration

  • LH concentration

Secondary Outcomes (1)

  • endometrial development

Interventions

0.15mg desogestrel /0.03mg ethinyl estradiolDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female volunteers of childbearing potential;
  • Are first time users of OCs or have discontinued OCs at least 1 month prior to study entry;
  • Aged between 18 and 35 years (extremes included);
  • Normal body mass index (18-38);
  • Has signed informed consent form;
  • Is in good health as confirmed by medical history, physical examination, and PAP smear or colposcopy within the past 12 months with normal results.

You may not qualify if:

  • Any contraindication for oral contraceptive use;
  • Irregular menstrual cycles
  • Ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
  • Pregnancy (suspected or diagnosed) or lactation;
  • Use of disallowed concomitant therapy;
  • 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;
  • Known, or suspected, carcinoma of the breast;
  • Known, or suspected, estrogen-dependent neoplasia;
  • +3 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 (3)

  • 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

  • Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.

    PMID: 12748128BACKGROUND

  • 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

MeSH Terms

Interventions

Desogestrel

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Roger A Pierson, MS PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
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

February 1, 2002

Study Completion

December 1, 2002

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

CA(1)