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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: NOMAC-E2 (Drug); LNG-EE (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck

Secondary outcome:

Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting

Number of Participants With an Occurrence of Absence of Withdrawal Bleeding

Number of Participants With an Occurrence of Breakthrough Bleeding

Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

Number of Participants With an Occurrence of Early Withdrawal Bleeding

Number of Participants With an Occurrence of Continued Withdrawal Bleeding

Average Number of Breakthrough Bleeding-Spotting Days

Average Number of Withdrawal Bleeding-spotting Days

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion criteria:

- Sexually active women, at risk for pregnancy and not planning to use condoms

during treatment;

- At least 20 but not older than 35 years of age at the time of screening;

- BMI = 17 and = 35;

- Good physical and mental health;

- Willing to give informed consent in writing;

- Willing to take part in the trial for two years.

Exclusion criteria:

- Family history of osteoporotic fracture below the age of 70;

- Postgastrectomy;

- History of eating disorder, viz. anorexia nervosa, bulimia;

- Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's

disease);

- Rheumatoid arthritis;

- Significant scoliosis;

- Fasting parathyroid hormone (PTH) outside the reference range at screening;

- Fasting calcitonin outside the reference range at screening;

- Prolactin above the reference range (hyperprolactinemia) at screening;

- Fasting cholesterol and/or triglycerides above the reference range for age at

screening (treatment with lipid lowering drugs not allowed);

- Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;

- Smoking more than ten cigarettes/day;

- Use of more than two units of alcohol a day;

- Use of one or more of the following drugs:

- gonadotropin releasing hormone (GnRH) analogues (also past use for more than six

months at any time, or for any period of time less than six months ago is a contraindication);

- systemic or inhaled administration of corticosteroids (also past use for more

than one year, less than five years ago or any period of time in the past year is a contraindication);

- thiazide diuretics;

- thyroid hormone;

- bisphosphonates;

- calcium supplementation in combination with vitamin D supplementation/

calcitonin;

- ever treatment after childhood with fluorides;

- Contraindications for contraceptive steroids

- An abnormal cervical smear (i. e.: dysplasia, cervical intraepithelial

neoplasia[CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;

- Clinically relevant abnormal laboratory result at screening as judged by the

investigator;

- Use of an injectable hormonal method of contraception; within 6 months of an

injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;

- Within 12 months after a pregnancy prior to the start of trial medication;

- Breastfeeding or within 12 months after stopping breastfeeding prior to the

start of trial medication;

- Present use or use within 2 months prior to the start of the trial medication of

the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);

- Administration of investigational drugs and/or participation in another clinical

trial within 2 months prior to the start of the trial medication or during the trial period.

Locations and Contacts

Additional Information

Starting date: September 2006
Last updated: February 12, 2015

Page last updated: August 23, 2015

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