Trials Sponsors Conditions Drugs Pricing

Conditions

Ovarian Suppression

Keywords

Ovarian SuppressionOral ContraceptivesObese and Normal BMI

Outcome Measures

Primary Outcomes (1)

Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined): 1. no activity 2. potential activity 3. nonactive follicle-like structure 4. active follicle-like structure 5. luteinized unruptured follicle 6. ovulation Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score.
Up to 8 biweekly visits from start of OCP therapy

Secondary Outcomes (2)

Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Screening (baseline) and follow-up 1 (exit)
Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.
24 hours during week 3 of follow-up cycle

Study Arms (2)

Normal Weight group

ACTIVE COMPARATOR

Participants with a BMI of 19-24.9 kg/m\^2

Drug: Low dose formulationDrug: High dose formulation

Obese group

ACTIVE COMPARATOR

Participants with a BMI of 30-39.9 kg/m\^2

Drug: Low dose formulationDrug: High dose formulation

Interventions

Low dose formulationDrug

Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.

Also known as: Low dose

Normal Weight groupObese group

High dose formulationDrug

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Aged 18-35
Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m\^2

Sponsors & Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIHcollaborator
Columbia University
Otherlead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Related Publications (2)

Mayeda ER, Torgal AH, Westhoff CL. Weight and body composition changes during oral contraceptive use in obese and normal weight women. J Womens Health (Larchmt). 2014 Jan;23(1):38-43. doi: 10.1089/jwh.2012.4241. Epub 2013 Oct 24.
PMID: 24156617DERIVED
Westhoff CL, Torgal AH, Mayeda ER, Stanczyk FZ, Lerner JP, Benn EKT, Paik M. Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):275-283. doi: 10.1097/AOG.0b013e3181e79440.
PMID: 20664386DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Dosage FormsContraceptives, Oral

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, Pharmaceutical

Results Point of Contact

Title: Carolyn Westhoff
Organization: Columbia University

Study Officials

Carolyn Westhoff, MD, MSc
Columbia University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

226 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

July 2006

Actual (reported)

Obesity, Oral Contraception, and Ovarian Suppression

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Normal Weight group

Obese group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Normal Weight group

Obese group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations