Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

NCT00563576 | Completed Results

• 1 other identifier: AAAC6363
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.

Conditions

Metrorrhagia

Keywords

Depo-Provera; Medroxyprogesterone Acetate; Metrorrhagia; Irregular Bleeding

Outcome Measures

Primary Outcomes (1)

• Mean Number of Bleeding or Spotting Days

  Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.

  3 months

Secondary Outcomes (3)

• Percentage of Users Who Were Satisfied With Femring

  3 months

• Number of Subjects Who Receive a 2nd Injection of Depo-Provera

  3 months

• Percentage of Subjects Who Receive a 3rd Injection

  6 months

Study Arms (2)

Depo-Provera/Femring

EXPERIMENTAL

Subjects will receive an estrogen vaginal ring (100 mcg) during the first 90 days of Depo-Provera use.

Drug: Femring®; Drug: DepoProvera ®

Depo-Provera Injection Alone

OTHER

Subjects will receive Depo-Provera intramuscular injection.

Drug: DepoProvera ®

Interventions

Femring® DRUG

Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use. Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 mm. Femring® 0.1 mg/day has a central core containing 24.8 mg of estradiol acetate which releases at a rate equivalent to 0.1 mg of estradiol per day for 3 months.

Also known as: Estradiol Acetate Vaginal Ring

Depo-Provera/Femring

DepoProvera ® DRUG

Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.

Also known as: Depot Medroxyprogesterone Acetate (DMPA)

Depo-Provera Injection Alone; Depo-Provera/Femring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18 or older who are initiating Depo-Provera for contraception
• English or Spanish-speaking
• Have a negative urine pregnancy test

You may not qualify if:

• Contraindications to either Depo-Provera or Femring (estrogen vaginal ring)
• Have used Depo-Provera or Mirena in the prior 6 months
• Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Title X Family Planning Clinic

New York, New York, 10032, United States

Location

Related Publications (17)

• Alvarez-Sanchez F, Brache V, Thevenin F, Cochon L, Faundes A. Hormonal treatment for bleeding irregularities in Norplant implant users. Am J Obstet Gynecol. 1996 Mar;174(3):919-22. doi: 10.1016/s0002-9378(96)70326-5.

  PMID: 8633669 BACKGROUND

• Belsey EM, Machin D, d'Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60. doi: 10.1016/0010-7824(86)90006-5.

  PMID: 3539509 BACKGROUND

• Dieben TO, Roumen FJ, Apter D. Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring. Obstet Gynecol. 2002 Sep;100(3):585-93. doi: 10.1016/s0029-7844(02)02124-5.

  PMID: 12220783 BACKGROUND

• Goldberg AB, Cardenas LH, Hubbard AE, Darney PD. Post-abortion depot medroxyprogesterone acetate continuation rates: a randomized trial of cyclic estradiol. Contraception. 2002 Oct;66(4):215-20. doi: 10.1016/s0010-7824(02)00391-8.

  PMID: 12413614 BACKGROUND

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  PMID: 8863083 BACKGROUND

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  PMID: 10715369 BACKGROUND

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  PMID: 10520615 BACKGROUND

• Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94. doi: 10.1016/s0010-7824(02)00514-0.

  PMID: 12618252 BACKGROUND

• Paul C, Skegg DC, Williams S. Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. Contraception. 1997 Oct;56(4):209-14. doi: 10.1016/s0010-7824(97)00140-6.

  PMID: 9408701 BACKGROUND

• Polaneczky M, Liblanc M. Long-term depot medroxyprogesterone acetate (Depo-Provera) use in inner-city adolescents. J Adolesc Health. 1998 Aug;23(2):81-8. doi: 10.1016/s1054-139x(98)00014-7.

  PMID: 9714170 BACKGROUND

• Rager KM, Fowler A, Omar HA. Successful treatment of depot medroxyprogesterone acetate-related vaginal bleeding improves continuation rates in adolescents. ScientificWorldJournal. 2006 Mar 19;6:353-5. doi: 10.1100/tsw.2006.69.

  PMID: 16547584 BACKGROUND

• Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. doi: 10.1016/j.jadohealth.2006.10.018.

  PMID: 17185202 BACKGROUND

• Said S, Omar K, Koetsawang S, Kiriwat O, Srisatayapan Y, Kazi A, Ajmal F, Wynter HH, Pretnar-Darovec A, Benitez IB. A multicentered phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100 mg or 150 mg: II. The comparison of bleeding patterns. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1987 Jun;35(6):591-610. doi: 10.1016/s0010-7824(87)80019-7.

  PMID: 2959448 BACKGROUND

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  PMID: 8982739 BACKGROUND

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  PMID: 8692507 BACKGROUND

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  PMID: 14551014 BACKGROUND

• Multinational comparative clinical evaluation of two long-acting injectable contraceptive steroids: noresthisterone oenanthate and medroxyprogesterone acetate. 2. Bleeding patterns and side effects. Contraception. 1978 May;17(5):395-406.

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MeSH Terms

Conditions

Metrorrhagia

Interventions

Estradiol; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; 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; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Results Point of Contact

• Title: Carolyn Westhoff
• Organization: Columiba University

clw3@columbia.edu

212-305-4805

Study Officials

• Angela R Dempsey, MD, MPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Carolyn Westhoff, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 15, 2021
• Results First Posted: July 21, 2011

Record last verified: 2021-12

Locations

US (1)