A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

NCT00789802 | Completed Results DMC

• 1 other identifier: 07-1026
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.

Conditions

Contraception; Bleeding

Keywords

contraception; progestin contraception; intrauterine contraception; unscheduled bleeding; placebo

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding and Spotting Days

  The median number of bleeding and spotting days reported at 12 weeks.

  12 weeks

Secondary Outcomes (3)

• Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.

  16 weeks

• Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.

  12 weeks

• Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups

  12 weeks

Study Arms (3)

transdermal estradiol

EXPERIMENTAL

participants will be randomized to transdermal estradiol

Drug: transdermal estradiol

oral naproxen

EXPERIMENTAL

participants will be randomized to oral naproxen

Drug: naproxen

oral placebo

PLACEBO COMPARATOR

participants will be randomized to oral placebo

Drug: oral placebo

Interventions

transdermal estradiol DRUG

transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Also known as: Climara

transdermal estradiol

naproxen DRUG

naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks

Also known as: Naprosyn, Anaprox

oral naproxen

oral placebo DRUG

oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

oral placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be of reproductive age from 18 to 45 years
• Must be choosing LNG-IUC for contraception
• Must be English-speaking
• Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study
• Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study
• Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled
• Be willing and able to provide informed consent

You may not qualify if:

• Known or suspected pregnancy
• Contraindication to estrogen use, such as presence or history of:
• venous thromboembolism
• Arterial thrombosis
• Thrombophilia disorders, or known family history of
• Hypertension
• Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years
• Recent or planned future major surgery which will result in prolonged immobilization during the study period
• Presence or history of severe hepatic disease or liver tumors
• Known or suspected estrogen-dependent neoplasm
• Vaginal bleeding of unknown etiology
• Any cigarette smoking and age over 35 years
• Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of:
• Gastrointestinal ulcer disease
• Renal insufficiency or failure

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American College of Obstetricians and Gynecologists: collaborator

Study Sites (1)

Washington University School fo Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Estradiol; Naproxen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Tessa Madden
• Organization: Washington University

maddent@wustl.edu

3147471331

Study Officials

• Tessa E Madden, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 20, 2018
• Results First Posted: December 11, 2014

Record last verified: 2018-03

Locations

US (1)