Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation - Full Text View

Sponsor:	Columbia University
Collaborator:	Anonymous
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00563576

Purpose

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.

Condition	Intervention
Metrorrhagia	Drug: Femring® Drug: DepoProvera ®

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Medroxyprogesterone 17-acetate Estradiol dipropionate Estradiol cypionate Medroxyprogesterone Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Mean Number of Bleeding or Spotting Days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Percentage of Users Who Were Satisfied With Femring [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.
Number of Subjects Who Receive a 2nd Injection of Depo-Provera [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Percentage of Subjects Who Receive a 3rd Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	September 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Depo-Provera/Femring Subjects will receive an estrogen vaginal ring (100 mcg) during the first 90 days of Depo-Provera use.	Drug: Femring® 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. Other Name: Estradiol Acetate Vaginal Ring Drug: DepoProvera ® 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. Other Name: Depot Medroxyprogesterone Acetate (DMPA)
No Intervention: Depo-Provera Injection Alone Subjects will receive Depo-Provera intramuscular injection.	Drug: DepoProvera ® 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. Other Name: Depot Medroxyprogesterone Acetate (DMPA)

Arms

Assigned Interventions

Experimental: Depo-Provera/Femring

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

Drug: Femring®

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.

Other Name: Estradiol Acetate Vaginal Ring

Drug: DepoProvera ®

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.

Other Name: Depot Medroxyprogesterone Acetate (DMPA)

No Intervention: Depo-Provera Injection Alone

Subjects will receive Depo-Provera intramuscular injection.

Drug: DepoProvera ®

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.

Other Name: Depot Medroxyprogesterone Acetate (DMPA)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563576

Locations

United States, New York
Title X Family Planning Clinic
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Anonymous

Investigators

Principal Investigator:	Angela R Dempsey, MD, MPH	Medical University of South Carolina
Principal Investigator:	Carolyn Westhoff, MD, MSc	Columbia University

More Information

Publications:

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.

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.

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.

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.

Harel Z, Biro FM, Kollar LM, Rauh JL. Adolescents' reasons for and experience after discontinuation of the long-acting contraceptives Depo-Provera and Norplant. J Adolesc Health. 1996 Aug;19(2):118-23.

Hubacher D, Goco N, Gonzalez B, Taylor D. Factors affecting continuation rates of DMPA. Contraception. 1999 Dec;60(6):345-51.

Lim SW, Rieder J, Coupey SM, Bijur PE. Depot medroxyprogesterone acetate use in inner-city, minority adolescents: continuation rates and characteristics of long-term users. Arch Pediatr Adolesc Med. 1999 Oct;153(10):1068-72.

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.

Paul C, Skegg DC, Williams S. Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. Contraception. 1997 Oct;56(4):209-14.

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.

Rager KM, Fpwler A, Omar HA. Successful treatment of depot medroxyprogesterone acetate-related vaginal bleeding improves continuation rates in adolescents. ScientificWorldJournal. 2006 Mar 19;6:353-5.

Rickert VI, Tiezzi L, Lipshutz J, León J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8.

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.

Said S, Sadek W, Rocca M, Koetsawang S, Kirwat O, Piya-Anant M, Dusitsin N, Sethavanich S, Affandi B, Hadisaputra W, Kazi A, Ramos RM, d'Arcangues C, Belsey EM, Noonan E, Olayinka I, Pinol A. Clinical evaluation of the therapeutic effectiveness of ethinyl oestradiol and oestrone sulphate on prolonged bleeding in women using depot medroxyprogesterone acetate for contraception. World Health Organization, Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Long-acting Systemic Agents for Fertility Regulation. Hum Reprod. 1996 Oct;11 Suppl 2:1-13.

Sangi-Haghpeykar H, Poindexter AN 3rd, Bateman L, Ditmore JR. Experiences of injectable contraceptive users in an urban setting. Obstet Gynecol. 1996 Aug;88(2):227-33.

Speroff L. Efficacy and tolerability of a novel estradiol vaginal ring for relief of menopausal symptoms. Obstet Gynecol. 2003 Oct;102(4):823-34.

[No authors listed] 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.

Responsible Party:	Angela Dempsey-Fanning, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:	NCT00563576 History of Changes
Other Study ID Numbers:	AAAC6363, Depo with Femring
Study First Received:	November 21, 2007
Results First Received:	October 11, 2010
Last Updated:	September 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Depo-Provera
Medroxyprogesterone Acetate
Metrorrhagia
Irregular Bleeding

Additional relevant MeSH terms:

Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone Acetate
Medroxyprogesterone

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 09, 2012