Not Signed In -
Ethinyl Estradiol and Norethindrone (Oral Contraceptive) |
Brevicon; Estrostep 21; Estrostep Fe; Gencept 0.5/35; Gencept 1/35; Gencept 10/11; Genora 0.5/35; Genora 1/35; Jenest-28; Loestrin 21 1.5/30; Loestrin 21 1/20; Loestrin Fe 1.5/30; Loestrin Fe 1/20; Microgestin Fe 1.5/30; Microgestin Fe 1/20; Modicon; N. E. E.; Necon 0.5/35; Necon 1/35; Necon 10/11; Necon 7/7/7; Nelova 0.5/35 E; Nelova 1/35 E; Nelova 10/11; Norcept-E 1/35; Norethin 1/35 E; Norinyl 1+35; Nortrel 0.5/35; Nortrel 1/35; Nortrel 7/7/7; Ortho-Novum 1/35; Ortho-Novum 10/11; Ortho-Novum 7/7/7; Ovcon-35; Ovcon-50; Tri-Norinyl |
Clinical Trial: A Study to Evaluate Suppression of the Pituitary-Ovarian Axis with Three Different Oral Contraceptive Regimens
This study is currently recruiting patients.
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Purpose
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] Drug: Seasonique (LNG/EE and EE) Drug: Portia (LNG/EE) | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title: A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis with Three Different Regimens of Oral Contraceptive Pills
Further Study Details:
Primary Outcomes: Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
Secondary Outcomes: Compare the differences in hormone withdrawal symptoms; Compare differences in ovarian follicular development before, during and after the 7-day hormone free interval or ethinyl estradiol-supplemented intervals.
Expected Total Enrollment: 36
Secondary Outcomes: Compare the differences in hormone withdrawal symptoms; Compare differences in ovarian follicular development before, during and after the 7-day hormone free interval or ethinyl estradiol-supplemented intervals.
Expected Total Enrollment: 36
Study start: June 2005; Expected completion: April 2006
Last follow-up: February 2006; Data entry closure: March 2006
Eligibility
Ages Eligible for Study: 18 Years - 35 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Premenopausal
- Not pregnant or breastfeeding
- Weight <200 lbs
- Currently taking oral contraceptives in the standard 28-day regimen for at least two months
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking > 10 cigarettes per day
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00117273
Arlene Santhouse, PharmD 610-747-2679 asanthouse@barrlabs.com
Duawn Campellone 610-747-2679 dcampellone@barrlabs.com
Duawn Campellone 610-747-2679 dcampellone@barrlabs.com
More Information
Study ID Numbers: DR PSE 310
Record last reviewed: June 2005
Last Updated: July 18, 2005
Record first received: July 5, 2005
ClinicalTrials.gov Identifier: NCT00117273
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: June 2005
Last Updated: July 18, 2005
Record first received: July 5, 2005
ClinicalTrials.gov Identifier: NCT00117273
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- Brevicon (Drug Digest)
- Estrostep 21 (Drug Digest)
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