Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)

NCT00475189 | Completed

• 1 other identifier: 60783
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner. It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen. It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.

Conditions

Pelvic Pain; Headaches; Emotional

Keywords

birth control; PMS; headaches; mood swings; pelvic pain

Outcome Measures

Primary Outcomes (2)

• Use of the Scott and White (S&W) Daily Symptoms Calendar, which records patient's subjective rating of mood, pelvic pain, flow, headache, and number and dose of pain medicines taken.

  8 months

• Measuring the levels of endogenous hormone (estradiol) in order to correlate serum estradiol levels with withdrawal symptoms during and after the two OC types (4-days versus 7-days) of hormone free intervals.

  one month

Secondary Outcomes (1)

• satisfaction Surveys

  given midway through the study and at the end of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: loestrin 24/4 vs loestrin 1/20

II

ACTIVE COMPARATOR

loestrin 1/20 given 1 tab 21/7

Drug: loestrin 1/20

Interventions

loestrin 24/4 vs loestrin 1/20 DRUG

One month of loestrin 1/20 then randomized to Loestrin 24/4 or Loestrin 1/20 x 3 months. After 3 months if randomized to 1/20 will be switched to 24/4 if already on 24/4 will be given a choice which OC they want to continue for 3 more months.

Also known as: Brand name for Loestrin FE 1/20 is Junel FE and Microgestin FE.

1

loestrin 1/20 DRUG

loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE

Also known as: Junel FE, Microgestin FE

II

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• current users (\>2 months) of a combination hormonal contraceptive (OC, contraceptive ring, contraceptive patch) with at least the most recent cycle ending with a 7 day HFI
• age 18-48
• BMI of 40 or less
• not desiring to become pregnant during the study time (about 8 months)
• capable and reliable in regards to recording and maintaining a daily symptoms log

You may not qualify if:

• a condition which will not allow you to use combination hormonal contraception; including a past or present history of diabetes, high blood pressure, stroke, breast cancer, heart attacks, blood clots, liver disease, or systemic lupus erythematosus.
• are pregnant or plan to become pregnant in the next 8 months or while you are in the study.
• a smoker greater than or equal to 35 years of age. You smoke 10 or more cigarettes a day and you are under the age of 35.

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• Warner Chilcott: collaborator

Study Sites (1)

Scott & White Hospital and Clinic

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Pelvic Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Sulak, MD

  Scott and White Hospital & Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

US (1)