NCT00511342

Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

An Open-Label, Randomized, Single Center Trial in Healthy Young Women, to Evaluate the Effects of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg NOMAC and 1.5 mg E2 on Bone Mineral Density (BMD) Compared to a Monophasic COC Containing 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	NOMAC-E2	Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
DRUG	LNG-EE	Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-08-03
• Last updated: 2022-02-09
• Results posted: 2011-08-29